Label: AIR AND WATER HAND SANITIZER KIT- ethyl 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 September 21, 2020

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  • AIR&WATER Merry Peppermint Hand Sanitizer

  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin that could cause disease. • When water, soap and towel are not available. • Recommended for repeated use.

  • Warnings

    For external use only: hands.

    Flammable. Keep away from fire or flame.

    When using this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyes thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.

    Stop use and ask a doctor if • Redness or irritation develop • Condition persists for more than 72 hours.

    Keep out of reach of children. • Children should be supervised by an adult when using this product. • If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • Wet hands thoroughly with product and allow to dry without wiping. • No rinsing required. • For children under 6, use only under adult supervision. • Not recommended for infants.

  • STORAGE AND HANDLING

    Other information • Store below 105°F (40°C). • May discolor certain fabrics. • Harmful to wood finishes & plastics.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red 40 (CI 16035), FD & C Yellow 6 (CI 15985), FD & C Violet 2 (CI 60725), FD & C Blue 1 (CI 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200).

  • SPL UNCLASSIFIED SECTION

    70% Alcohol

    Manufactured for and distributed by Pearl world Inc, NY, NY 10019
    Pearlworldinc.com All rights reserved. Designed in the USA. Made in PRC.

  • AIR&WATER Sugar Plum Hand Sanitizer

  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin that could cause disease. • When water, soap and towel are not available. • Recommended for repeated use.

  • Warnings

    For external use only: hands.

    Flammable. Keep away from fire or flame.

    When using this product • Keep out of eyes, ears, or mouth. • In case if eye contact, flush eyes thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.

    Stop use and ask a doctor if • Redness or irritation develop • Condition persists for more than 72 hours.

    Keep out of reach of children. • Children should be supervised by an adult when using this product. • if swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • Wet hands thoroughly with product and allow to dry without wiping. • No rinsing required. • For children under 6, use only under adult supervision. • Not recommended for infants.

  • STORAGE AND HANDLING

    Other information • Store below 105°F (40°C). • May discolor certain fabrics. • Harmful to wood finishes & plastics.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red 40 (CI 16035), FD & C Yellow 6 (CI 15985), FD & C Violet 2 (CI 60725), FD & C Blue 1 (CI 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33 (CI 17200).

  • SPL UNCLASSIFIED SECTION

    70% Alcohol

    Manufactured for and distributed by Pearl World Inc, NY, NY 10019 Pearlworldinc.com

    All rights reserved. Designed in the USA. Made in PRC.

  • AIR&WATER Snow Mint Hand Sanitizer

  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin that could cause disease. • When water, soap and towel are not available. • Recommended for repeated use.

  • Warnings

    For external use only: hands.

    Flammable. Keep away from fire or flame.

    When using this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyes thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.

    Stop use and ask a doctor if • Redness or irritation develop. • Condition persists for more than 72 hours.

    Keep out of reach of children. • Children should be supervised by an adult when using this product. • If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • Wet hands thoroughly with product and allow to dry without wiping. • No rinsing required. • For children under 6, use only under adult supervision. • Not recommended for infants.

  • STORAGE AND HANDLING

    Other information • Store below 105°F (40°C) • May discolor certain fabrics. • Harmful to wood finishes & plastics.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red 40 (CI 16035), FD & C Yellow 6 (CI 15985), FD & C Violet 2 (CI 60725), FD & C Blue 1 (CI 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200).

  • SPL UNCLASSIFIED SECTION

  • AIR&WATER Christmas Berry Hand Sanitizer

  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin that could cause disease. • When water, soap and towel are not available. • Recommended for repeated use.

  • Warnings

    For external use only: hands.

    Flammable. Keep away from fire or flame.

    When using this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyes thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.

    Stop use and ask a doctor if • Redness or irritation develop. • Condition persists for more than 72 hours.

    Keep out of reach of children. • Children should be supervised by an adult when using this product. • If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • Wet hands thoroughly with product and allow to dry without wiping. • No rinsing required. • For children under 6, use only under adult supervision. • Not recommended for infants.

  • STORAGE AND HANDLING

    Other information • Store below 105°F (40°C). • May discolor certain fabrics. • Harmful to wood finishes & plastics.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Triethanolamine, Carbomer, Aloe Barbadensis Leaf Extract, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red 40 (CI 16035), FD & C Yellow 6 (CI 15985), FD & C Violet 2 (CI 60725), FD & C Blue 1 (CI 42090), FD & C Yellow 5 (CI 19140), FD & C Red 33(CI 17200).

  • SPL UNCLASSIFIED SECTION

    70% Alcohol

    Manufactured for and distributed by Pearl world Inc, NY, NY 10019

    Pearlworldinc.com All rights reserved. Designed in the USA. Made in PRC.

  • Packaging

    IMAGE

    IMAGE

  • INGREDIENTS AND APPEARANCE
    AIR AND WATER HAND SANITIZER KIT 
    ethyl alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69933-404
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69933-404-601 in 1 KIT; Type 0: Not a Combination Product09/18/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 60 mL
    Part 21 BOTTLE 60 mL
    Part 31 BOTTLE 60 mL
    Part 41 BOTTLE 60 mL
    Part 1 of 4
    AIR AND WATER  HAND SANITIZER - MERRY PEPPERMINT
    ethyl alcohol gel
    Product Information
    Item Code (Source)NDC:69933-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69933-400-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Part 2 of 4
    AIR AND WATER  HAND SANITIZER - SUGAR PLUM
    ethyl alcohol gel
    Product Information
    Item Code (Source)NDC:69933-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69933-401-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Part 3 of 4
    AIR AND WATER  HAND SANITIZER - SNOW MINT
    ethyl alcohol gel
    Product Information
    Item Code (Source)NDC:69933-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69933-402-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Part 4 of 4
    AIR AND WATER  HAND SANITIZER - CHRISTMAS BERRY
    ethyl alcohol gel
    Product Information
    Item Code (Source)NDC:69933-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69933-403-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Labeler - Pearl World Inc. (043130142)
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