FDA Label for Hand Sanitizing And Moisturizing Wipes
View Indications, Usage & Precautions
Hand Sanitizing And Moisturizing Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Generic Specialties, Inc.. 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 sanitizing & moisturizing wipes 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 sanitizing & moisturizing wipes are 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 (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (67%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin
Sodium EDTA
PEG 40 Hydrogenated Castor Oil
Fragrance
Aqua.
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)
Isopropyl Alcohol 67% v/v. Purpose: Antimicrobial, Antibacterial
Purpose
Antimicrobial, Antibacterial Hand sanitizing and moisturizing wipes
Use
Hand Sanitizing wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on injured or irritated skin
- If you are sensitive to any of its ingredients
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 at 1-800-222-1222
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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 at 1-800-222-1222
Directions
- Wipe hands thoroughly with a towelette. Allow to dry. Discard after a single-use. For External use only.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Aqua, Glycerin, Sodium EDTA, PEG 40 Hydrogenated Castor Oil, Fragrance
Recent Major Changes
Hand sanitizing wipes to help reduce bacteria that potentially can cause disease. for use when soap and water are not available.
Wipe hands thoroughly with a towelette. Allow to dry. Discard after a single-use. For External use only.
* Please review the disclaimer below.