Label: MOISTURISING HAND SANITIZER- alcohol gel

  • 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 March 29, 2022

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  • Active Ingredient(s)

    Alcohol 71% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    • Hand Sanitizer to help reduce bacteria that potentially can cause disease.
    • Recommended for repeated, frequent use.
  • Warnings

    For external use only. Flammable. Keep away from fire or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    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 medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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.

  • Directions

    • Place enough product in your palm to thoroughly cover your hands.
    • Rub hands together until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store at the temperature below 110F (43C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    purified water USP, acrylates/c10-30 alkyl acrylates crosspolymer, glycerin, hyaluronic acid, triethanolamine, phenoxyethanol, ethylhexylglycerin, fragrance

  • Package Label - Principal Display Panel

    Rescue Me by Rescue Spa

    Mositurising Hand Sanitizer

    bottle 250mL 250

    Rescue Me by Rescue Spa

    Mositurising Hand Sanitizer

    tube 70mL 70mL

    Rescue Me by Rescue Spa

    Mositurising Hand Sanitizer

    Sachet 50 x 0.07 fl. oz. (50 x 2 mL)

    outer labelinner label

    Rescue Me by Rescue Spa

    Mositurising Hand Sanitizer

    1.69 fl.oz. / 50 mL

    Outer labelInner label

  • INGREDIENTS AND APPEARANCE
    MOISTURISING HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79535-7001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONIC ACID (UNII: S270N0TRQY) 0.001 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.0009 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.2 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.2 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.0001 mL  in 100 mL
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 0.8 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79535-7001-11 in 1 CARTON07/22/2020
    150 in 1 POUCH
    12 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:79535-7001-02 mL in 1 POUCH; Type 0: Not a Combination Product07/24/2020
    3NDC:79535-7001-21 in 1 CARTON07/22/2020
    350 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:79535-7001-350 in 1 CARTON07/22/2020
    42 mL in 1 POUCH; Type 0: Not a Combination Product
    5NDC:79535-7001-51 in 1 CARTON07/22/2020
    570 mL in 1 TUBE; Type 0: Not a Combination Product
    6NDC:79535-7001-41 in 1 CARTON07/22/2020
    6250 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 finalpart333A07/22/2020
    Labeler - RESCUE SPA, INC. (026265658)
    Registrant - Oceanic SA (422218763)
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