Label: CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET kit

  • NDC Code(s): 65753-100-37, 65753-504-36
  • Packager: CoreTex Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 21, 2022

If you are a consumer or patient please visit this version.

  • Hand Sanitizer Active Ingredients

    SD Alcohol 40-B 62.5%

  • Hand Sanitizer Purpose

    Antimicrobial

  • Hand Sanitizer Uses

    Hand Sanitizer to help reduce bacteria on the skin.

  • Hand Sanitizer Warnings

    Flammable. Keep away from heat or flame.

    For external use only.

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash appears and lasts.

    Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.

  • Hand Sanitizer Directions

    Put enough product in your palm to cover hands and rub hands together briskly until dry.

  • Hand Sanitizer Inactive Ingredients

    actinidia chinesis (kiwi) extract, aloe barbadenis leaf juice, aminomethyl propanol, brassica oleracea italica (broccoli) extract, cannabis sativa (hemp) seed extract, carbomer citrullus vulgaris (watermelon) fruit extract, euterpe oleracea fruit extract, fragaria vesca (strawberry) fruit extract, glycerin, helianthus annus (sunfloer) seed oil, hippophae rhamnoides (sea buckthorn) fruit extract, lycium barbarum (goji) extract, myrciaria dubia (camu camu) fruit extract, propanediol, propylene glycol, punica granatum extract, rubus idaeus seed extract, tocopherol acetate (vitamin E acetate), vaccinium angustifolium (blueberry) extract, vaccinium macrocarpon (cranberry) fruit extract, vitis vinifera (grape) seed extra, water

  • Hand Sanitizer Other Information

    Store below 110 oF (43 o), Read the Safety Data Sheet for this Product. You may obtain an SDS from our website: www.coretexproducts.com or Call: 1-877-684-5774

  • SunX 30 Active Ingredients

    Avobenzone 1.0%

    Homosalate 5.0%

    Octinoxate 7.5%

    Octisalate 5.0%

    Oxybenzone 6.0%

  • SunX 30 Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

  • SunX 30 Uses

    • helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.
  • SunX 30 Warnings

    For external use only

    SunX 30
    Do Not Use

    • on damaged or broken skin

    When using this product

    • keep out of the eyes
    • rinse with water to remove

    Stop use and ask a doctor if

    • rash occurs
  • SunX 30 Keep out of reach of children

    If swallowed get medical help or contact a Poison Control center right away.

  • SunX 30 Directions

    • apply liberally and evenly 15 minutes before sun exposure
    • Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and after sun protection measures including:
    • limit time in the sun, especially from 10:00 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months of age: Ask a doctor
  • SunX 30 Other Information

    • protect this product from excessive heat or direct sun
  • SunX 30 Inactive Ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita extract, dimethicone, dimethyl capramide, ethylparaben, fragrance, glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale leaf extract, tetrasodium EDTA, triethanolamine, tocopherol, tocopherol acetate, water

  • SunX 30 Questions?

    Call: 1-877-684-5774

  • SunX 30 Lip Balm Active Ingredients

    Avobenzone…3.0%

    Homosalate…7.5%

    Octisalate…5.0%

    Octocrylene…2.5%

    Oxybenzone…6.0%

  • SunX 30 Lip Balm Purpose

    Sunscreen

  • SunX 30 Lip Balm Uses

    Helps prevent sunburn.

  • SunX 30 Lip Balm Warnings

    For external use only.

    Do not use

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if

    • rash occurs

    When using this product

    • keep out of eyes. Rinse to remove.
  • SunX 30 Lip Balm Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • SunX 30 Lip Balm Directions

    • apply liberally 15 minutes before sun exposure
    • Use water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months of age: Ask a doctor
  • SunX 30 Lip Balm Sun Protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures:

    • limit time in the sun, especially from 10a.m.-2p.m.
    • wear long sleeved shirts, pants, hats, and sunglasses.
  • SunX 30 Lip Balm Inactive Ingredients

    Beeswax, castor oil, cocoa butter, coconut oil, shea utter

  • SunX 30Lip Balm Other information

    Protect this productfrom excessive heat and direct sun.

  • Anti-Itch Active Ingredients

    Camphor 0.1%

    Diphenhydramine hydrochloride 2%

    Zinc acetate 1%

  • Anti-Itch Purpose

    Extrenal analgesic

    Antihistamine

    Skin protectant

  • Anti-Itch Uses

    • For the temporary relief of itching and pain associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak, poison sumac.
    • dries the oozing and weeping of poison ivy, poison oak, poison sumac.
  • Anti-Itch Warnings

    For external use only

    Do Not Use

    • on chicken pox, blisters or on extensive areas of the skin
    • with any drugs containing diphenhydramine while using this product.

    When using this product

    • keep out of eyes.

    Stop use and ask a doctor if

    • conditions worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • Anti-Itch Keep out of reach of children

    If swallowed get medical help or contact Poison Control center right away.

  • Anti-Itch Directions

    • Adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed bu a doctor.
  • Anti-Itch Other Information

    • protect this product from excessive heat and direct sun.
  • Anti-Itch Inactive Ingredients

    citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, SD alcohol 40, sodium citrate, water (aqua).

  • Anti-Itch Questions?

    Call: 1-877-684-5774

  • Sting X Active Ingredients

    Benzocaine 6%

  • Sting X Purpose

    Topical Analgesic

  • Sting X Use

    For temporary pain relief from insect bites and stings

  • Sting X Warnings

    For external use only

    Do not use

    • in or near eyes
    • over large areas of the body
    • over raw or blistered areas
  • Sting X Stop use and ask a doctor if

    • conditions worsen or persist for more than 7 days or clear up and occur again within a few days
  • Sting X Keep out of reach of children.

    If swallowed get medical help or contact Poison Control center right away.

  • Sting X Directions

    Apply to affected area not more than 3 to 4 times daily, for adults and children 2 years of age or older.

  • Sting X Inactive Ingredients

    SD alcohol 40, water (aqua), glycerin, allantoin

  • Sting X Other Information

    Made in USA for CoreTex Products, Inc.

    Bakersfield, CA 93308

    www.CoreTexProducts.com (877)684-5774

  • Outdoor Professional Kit and Refill Kit Contents

    1 ea – Sun X SPF 30 Broad Spectrum Lotion Pouch

    1 ea – Sun X SPF 30 Broad Spectrum Multi-Pack Pouch w/Towelette
    1 ea – Sun X SPF 30 Lip Balm
    2 ea – Bug X 30 Insect Repellent Towelette
    2 ea – Ivy X Pre-Contact Barrier Towelette
    2 ea – Ivy X Post-Contact Cleanser Towelette
    2 ea – Burn X Lite Cooling Gel Pouch
    1 ea – Anti-Itch Gel Pouch
    1 ea – Sting X Pain Relief Pad
    1 ea – Hand Sanitizer Gel Pouch

  • Professional Outdoor Kit Label

    Professional Outdoor Kit

  • Professional Outdoorkit Refill

    Outdoor Kit Refill

  • Hand Sanitizer Package Label

    hand sanitizer label

  • SunX 30 Label

    SunX 30

  • SunX 30 Multipack with Towelette Label

    SunX 30 towelette

  • SunX 30 Lip Balm Label

    Lip Balm

  • Anti-Itch Label

    anti-itch label

  • Sting X Label

    Sting X label

  • INGREDIENTS AND APPEARANCE
    CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET 
    coretex professional outdoor skin protection wallet kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-504
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-504-361 in 1 KIT; Type 0: Not a Combination Product11/27/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 44 mL
    Part 21 POUCH 7 g
    Part 31480926 APPLICATOR 65753105 mL
    Part 41 POUCH 1 mL
    Part 51 POUCH 1.1 mL
    Part 61 POUCH 3.5 mL
    Part 1 of 6
    CORETEX SUN X SPF 30 
    avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Item Code (Source)NDC:65753-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    Product Characteristics
    Colorwhite (Thick White Lotion) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-100-3744 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/25/2013
    Part 2 of 6
    SUN X MULTI-PACK SPF 30 THICK 
    avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Item Code (Source)NDC:65753-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2017
    Part 3 of 6
    SUN XSPF 30 BROAD SPECTRUM SUNSCREEN LIP BALM 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lipstick
    Product Information
    Item Code (Source)NDC:65753-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    144.4 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2017
    Part 4 of 6
    CORETEX ANTI-ITCH GEL 
    camphor, diphenhydramine, zinc acetate gel
    Product Information
    Item Code (Source)NDC:65753-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.1 g  in 100 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 g  in 100 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL 1-ALLYL ETHER (UNII: QRB8092KPK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/25/2019
    Part 5 of 6
    STINGX 
    benzocaine swab
    Product Information
    Item Code (Source)NDC:65753-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.1 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/25/2019
    Part 6 of 6
    CORETEX ANTIBACTERIAL HAND SANITIZER 
    sd alcohol liquid
    Product Information
    Item Code (Source)NDC:65753-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
    HIPPOPHAE RHAMNOIDES FRUIT JUICE (UNII: UC3P08EB3Y)  
    PROPYLENE GLYCOL 1-BUTYRATE (UNII: PUV901J64H)  
    VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW)  
    ACTINIDIA CHINENSIS WHOLE (UNII: 8HTD3WU8LH)  
    BRASSICA OLERACEA VAR. ITALICA WHOLE (UNII: DW4954EP53)  
    CANNABIS SATIVA SEED (UNII: QE567Z26NG)  
    PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)  
    FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)  
    VACCINIUM MACROCARPON WHOLE (UNII: D11KO7O2DX)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13.5 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/27/2019
    Labeler - CoreTex Products Inc (061944620)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises017701475manufacture(65753-350, 65753-400)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoreTex Products Inc061944620pack(65753-504, 65753-200, 65753-105, 65753-102, 65753-100, 65753-350, 65753-400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source080354456manufacture(65753-100, 65753-102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose083819404manufacture(65753-105)
    Establishment
    NameAddressID/FEIBusiness Operations
    HealthSpecialty794053863manufacture(65753-200)