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

Sanidry by

Drug Labeling and Warnings

Sanidry by is a Otc medication manufactured, distributed, or labeled by QUIMICA ROSMAR S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SANIDRY 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77251-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77251-006-01	1275 mL in 1 BAG; Type 0: Not a Combination Product	01/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/04/2021

Labeler - QUIMICA ROSMAR S.A. DE C.V. (814223475)

Establishment
Name	Address	ID/FEI	Business Operations
QUIMICA ROSMAR S.A. DE C.V.		814223475	manufacture(77251-006)