Label: SANIDRY- alcohol cloth

  • 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 January 18, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    For hand sanitizing to decrease bacteria on the skin when water and soap are not available.

    Recommended for repeated use.

  • Warnings

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

  • Do not use

    • Do not use near eyes.
  • WHEN USING

    When using this product, do not use near eyes. If contact occurs, flush thoroughly with water.

  • STOP USE

    Stop use and contact a doctor if irritation or redness persists for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Remove wipes
    • Rub hands together briskly until dry. No rinsing required.
    • Do not reuse the towel, dispose of it immediately after use.
  • Other information

    • Store at temperature below 110F(43C)
    • Do not puncture or incinerate container
  • Inactive ingredients

    purified water USP, glycerin

  • Package Label - Principal Display Panel

    300 units NDC: 77251-006-01 Package Label. Principal Display Panel.

  • INGREDIENTS AND APPEARANCE
    SANIDRY 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77251-006
    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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77251-006-011275 mL in 1 BAG; Type 0: Not a Combination Product01/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/04/2021
    Labeler - QUIMICA ROSMAR S.A. DE C.V. (814223475)
    Establishment
    NameAddressID/FEIBusiness Operations
    QUIMICA ROSMAR S.A. DE C.V.814223475manufacture(77251-006)
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