CARE1 ISOPROPYL RUBBING ALCOHOL 72%- isopropyl alcohol liquid

Care1 Isopropyl Rubbing Alcohol 72% by

Drug Labeling and Warnings

Care1 Isopropyl Rubbing Alcohol 72% by is a Otc medication manufactured, distributed, or labeled by Lauree LLC, Care 1. 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. 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.
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)

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

WHEN USING

do not get into eyes

do not apply over large area of the body

do not use longer than 1 week

STOP USE

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

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

INGREDIENTS AND APPEARANCE

CARE1 ISOPROPYL RUBBING ALCOHOL 72% 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78975-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	72 mL  in 100 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78975-505-05	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/02/2020

Labeler - Lauree LLC (102938225)

Registrant - Care 1 (066368393)

Establishment
Name	Address	ID/FEI	Business Operations
Lauree LLC		102938225	manufacture(78975-505)