CDC70HS HAND SANITIZER- ethanol liquid 
Canadian Distribution Channel

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.

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CDC70HS Liquid 76984-442

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (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)

Alcohol 70% 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
CDC70HS 100ml, 500ml, 1890ml, 2L and 3,79L, 300 ml, 60 ml

Label for 100ml 76984-442-01

769844301 100ml

Label for 500ml 76984-442-02

500ml

Label for 1.89L 76984-442-03

1.89L 76984-442-03

Label for 2L 76984-442-04

Label for 2L  76984-442-04

Label for 3.79L 76984-442-05

Label for 3.79L  76984-442-05

Label for CDC70HS 300 ml 76984-442-06

300 ml 76984-442-06

Label for CDC70HS 60ml 76984-442-07

CDC70HS 60ml 76984-442-07

CDC70HS HAND SANITIZER 
ethanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76984-442
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76984-442-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2020
2NDC:76984-442-02500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2020
3NDC:76984-442-031890 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2020
4NDC:76984-442-042000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2020
5NDC:76984-442-053790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2020
6NDC:76984-442-06300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2020
7NDC:76984-442-0760 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/2020
Labeler - Canadian Distribution Channel (242043508)
Registrant - Canadian Distribution Channel (242043508)
Establishment
NameAddressID/FEIBusiness Operations
Canadian Distribution Channel242043508manufacture(76984-442)

Revised: 8/2020
Document Id: ac905e3a-8a04-4bcc-e053-2a95a90a107d
Set id: a40e27a1-61cb-7e7d-e053-2a95a90a5914
Version: 3
Effective Time: 20200810
 
Canadian Distribution Channel