Label: 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 May 11, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70% v/v

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • WARNINGS

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

    keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid

    contact with broken skin. Do not inhale or ingest.

    and ask a doctor if irritation or rash occurs.

    • Condition persists for more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    • Wet hands thoroughly with product and rub into skin until dry.
    • Children under 6 years of age should be supervised when using this product.
  • OTHER SAFETY INFORMATION

    Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics.

  • INACTIVE INGREDIENT

    Water, Carbomer, Triethanolamine.

  • QUESTIONS

    Call: Risan Cosmetics +52 462 606 6070

    Manufactured by Risan Cosmetics S.A. de C.V. Victorino de las Fuentes 487 Col. Barrio Nuevo P.C. 36530 Irapuato, Guanajuato, Mexico. Made in Mexico.

  • PRINCIPAL DISPLAY PANEL

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75668-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 L  in 1000 L
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E) 6 L  in 1000 L
    TROLAMINE (UNII: 9O3K93S3TK) 10 L  in 1000 L
    WATER (UNII: 059QF0KO0R) 284 L  in 1000 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75668-200-011000 L in 1 CONTAINER; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/11/2020
    Labeler - Risan Cosmetics S.A. de C.V. (812814244)
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