FDA Label for Sanidry
View Indications, Usage & Precautions
Sanidry Product Label
The following document was submitted to the FDA by the labeler of this product Quimica Rosmar S.a. De C.v.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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:
- 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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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.
Otc - When Using
When using this product, do not use near eyes. If contact occurs, flush thoroughly with water.
Otc - Stop Use
Stop use and contact a doctor if irritation or redness persists for more than 72 hours
Otc - 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
Recent Major Changes
Indications and Usage
Dosage and Administration
Active ingredients
Inactive ingredients
Package Label - Principal Display Panel
300 units NDC: 77251-006-01
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