Label: BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZERS CRANBERRY WINTER BERRY PEPPERMINT- alcohol kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 9, 2020

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  • BODY PRESCRIPTIONS Cranberry HAND SANITIZER ANTIBACTERIAL

    BODY PRESCRIPTIONS Cranberry HAND SANITIZER ANTIBACTERIAL

    Active Ingredient

    Alcohol 75%

    Purpose

    Antiseptic

  • Use

    ■ To decrease bacteria on the skin that could cause disease
    ■Recommended for repeated use

  • WARNINGS

    For external use only

    Flammable. Keep away from heat or flame

    When using this product, keep out of eyes, ears, and mouth 
    In case of contact with eyes, rinse eyes thoroughly with water

    Do not use

    • in children less than two months of age
    • on open skin wounds

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

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

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Blue 1, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Water,  Yellow 5

  • BODY PRESCRIPTIONS Winter Berry HAND SANITIZER ANTIBACTERIAL

    BODY PRESCRIPTIONS Winter Berry HAND SANITIZER ANTIBACTERIAL

  • Active Ingredient

    Alcohol 75%

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin that could cause disease

    ■Recommended for repeated use

  • Warnings

    For external use only

    Flammable. Keep away from heat or flame

    When using this product, keep out of eyes, ears, and mouth
    In case of contact with eyes, rinse eyes thoroughly with water

    Do not use

    • in children less than two months of age
    • on open skin wounds
  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing

  • Other Information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive Ingredients

    Blue 1, Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Yellow 5

  • BODY PRESCRIPTIONS Peppermint HAND SANITIZER ANTIBACTERIAL

    BODY PRESCRIPTIONS Peppermint HAND SANITIZER ANTIBACTERIAL

  • Active Ingredient

    Alcohol 75%

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin that could cause disease

    ■Recommended for repeated use

  • Warnings

    For external use only

    Flammable. Keep away from heat or flame

    When using this product, keep out of eyes, ears, and mouth
    In case of contact with eyes, rinse eyes thoroughly with water

    Do not use

    • in children less than two months of age
    • on open skin wounds
  • DO NOT USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing

  • Other Information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive Ingredients

    Blue 1, Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Yellow 5

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZERS CRANBERRY WINTER BERRY PEPPERMINT 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-320
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-320-011 in 1 KIT10/09/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 60 mL
    Part 21 BOTTLE 60 mL
    Part 31 BOTTLE 60 mL
    Part 1 of 3
    BODY PRESCRIPTIONS CRANBERRY HAND SANITIZER ANTIBACTERIAL 
    alcohol solution
    Product Information
    Item Code (Source)NDC:50563-317
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-317-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/09/2020
    Part 2 of 3
    BODY PRESCRIPTIONS WINTER BERRY HAND SANITIZER ANTIBACTERIAL 
    alcohol solution
    Product Information
    Item Code (Source)NDC:50563-318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-318-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/09/2020
    Part 3 of 3
    BODY PRESCRIPTIONS PEPPERMINT HAND SANITIZER ANTIBACTERIAL 
    alcohol solution
    Product Information
    Item Code (Source)NDC:50563-319
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-319-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/09/2020
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-320)
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