FDA Label for Care1 Isopropyl Rubbing Alcohol 72%
View Indications, Usage & Precautions
Care1 Isopropyl Rubbing Alcohol 72% Product Label
The following document was submitted to the FDA by the labeler of this product Lauree Llc. 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:
- Isopropyl Alcohol (75%, 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)
Isopropyl Alcohol 72% v/v. Purpose: Antiseptic
Purpose
First aid antiseptic
Use
Helps prevent the risk of infection in minor cuts, scrapes and burns.
Warnings
For external use only. Flammable. Keep away from heat or flame
Ask A Doctor Before Use
for deep wounds, animal bites or serious burns
Otc - When Using
•do not get into eyes
• do not apply over large area of the body
• do not use longer than 1 week
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.
Directions
• clean the affected area
• apply 1 to 3 times daily
Other Information
• does not contain, nor is intended as a substitute for grain or ethyl alcohol
• will produce serious gastric disturbances if taken internally
Inactive Ingredients
Purified water USP
Package Label - Principal Display Panel
473 ml NDC: 78975-505-05
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