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)
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.
Otc - When Using
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.
Otc - Stop Use
Stop use
- if the condition persists or gets worse
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Clean the affected area
- Remove wipes
- Rub together briskly until dry
- No rinsing required
- Do not reuse the towel, dispose immediately after use.
Other Information
- Do not apply internally
- Store at temperature below 110F(43C)
- Hold away from face when opening
Inactive Ingredients
purified water
Package Label - Principal Display Panel
300 units NDC: 77251-007-01 -000-00
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