CAREPURE 01- isopropyl alcohol liquid 
Carestream Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer 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

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.

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.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

208198 mL (55 gal)

60 mL Bottle

80 mL Bottle

208198 mL (55 gal) Drum

240 mL (8oz)

500 mL

1000 mL (1L)

4000 mL (4L)

4000 mL (4L)

10000 mL (10 L)

7571 mL (2 gal)

18927 mL (5 gal)

250 mL

CAREPURE  01
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31382-963
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31382-963-01208198 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:31382-963-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:31382-963-0380 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:31382-963-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:31382-963-05240 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:31382-963-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:31382-963-071000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
8NDC:31382-963-084000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
9NDC:31382-963-095000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
10NDC:31382-963-1010000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
11NDC:31382-963-117571 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
12NDC:31382-963-1218927 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
13NDC:31382-963-13250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Carestream Health, Inc. (793169512)

Revised: 4/2020
Document Id: a36fd127-2776-308a-e053-2a95a90a40e6
Set id: a36fcfb8-ed9b-3a54-e053-2995a90a4c20
Version: 1
Effective Time: 20200416
 
Carestream Health, Inc.