Label: GRIME STOPPERS INSTANT HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 February 18, 2021

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  • ACTIVE INGREDIENT(S)

    Ethyl Alcohol 70% v/v

  • PURPOSE

    Anitmicrobial

  • DOSAGE & ADMINISTRATION

    Topical Gel applied to outer surface of the body, specifically hands.

  • USE

    Gel hand sanitizer to help reduce bacteria on the skin that could cause disease or illness. Repeat use as needed.

  • WARNINGS

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

    When using this product

    • Keep out of eyes, ears, and mouth. In case of contact, flush thoroughly with water.
    • Avoid contact with broken wounds.
    • Do not ingest or inhale.

    Stop use and ask a doctor

    if irritation or rash appears and persists more than 72 hours.

    Keep out of the reach of children.

    • If swallowed, get medical help or contact the Poison Control Center right away.
  • DIRECTIONS

    • Apply to palm of your hand as needed.
    • Rub hands together to spread gel until dry.
    • No rinsing or towel required.
    • Children under 6 years of age consult physcian before use and supervise when using this product.
  • OTHER INFORMATION

    • Avoid freezing and store below 105°F (41°C)
    • May discolor or harm fabrics, wood finishes and plastics.
  • INACTIVE INGREDIENTS

    • Water
    • Triethanolamine
    • Carbomer
    • Propylene Glycol
    • Glycerin
    • Aloe Barbadensis Leaf Juice
    • Tocopheryl Acetate
  • Grime STOPPERS Instant Hand Sanitizer Gel

    53mL NDC: 63436-006-02

    53mL Label

    500ml NDC: 63436-006-16

    500mL Label

    3.78mL NDC: 63436-006-28

    3.78L Label

  • INGREDIENTS AND APPEARANCE
    GRIME STOPPERS INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63436-006
    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
    GLYCERIN (UNII: PDC6A3C0OX) 0.2 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.18 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.26 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.26 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63436-006-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/09/2020
    2NDC:63436-006-0253 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
    3NDC:63436-006-283.79 mL in 1 JUG; Type 0: Not a Combination Product09/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/09/2020
    Labeler - EMCO Electric International (122921948)
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