SANIDRY- alcohol cloth 
QUIMICA ROSMAR S.A DE C.V

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.

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77251-007 Sanidry
Hydrogen Peroxide 3%

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)

Hydrogen peroxide 3% v/v. Purpose: First Aid Antiseptic

Purpose

First Aid Antiseptic

Use

As an antiseptic to help prevent infection in minor cuts, scrapes, burns.

Warnings

For external use only.

Do not use

Do not use in the eyes or apply over large areas of the body

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Stop use

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

Directions

Other information

Inactive ingredients

purified water

Package Label - Principal Display Panel

300 units NDC: 77251-007-01 Package Label. Principal Display Panel.-000-00

SANIDRY 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77251-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77251-007-011275 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.V814223475manufacture(77251-007)

Revised: 1/2021
Document Id: b9354c76-ef51-650e-e053-2995a90a8300
Set id: b8411e12-39df-b099-e053-2a95a90a3b66
Version: 2
Effective Time: 20210118
 
QUIMICA ROSMAR S.A DE C.V