HAND SANITIZER- hypochlorous acid gel 
Kepter Mexico S.A de C.V

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Hand Sanitizer - Hypochlorous Acid

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

  1. Hypochlorous Acid (0.0005% volume/volume (v/v)).
  2. Triethanolamine (1.2% v/v).
  3. Edetic Acid (0.05% v/v).
  4. Carbopol (1.0% v/v).
  5. Demineralized water.

Active Ingredient(s)

Hypochlorous Acid 0.0005% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Antiseptic hand sanitizer to reduce germs on the skin. For use when soap and water not available.

Warnings

For external use only. Keep out of reach of children.

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 doctor: If irritation, rash or redness occurs. These may be signs of 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 doctor: If irritation, rash or redness occurs. These may be signs of serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store below 83F (30C).

Avoid freezing.

Inactive ingredients

demineralized water, triethanolamine, carbomer and stabilizers.

Package Label - Principal Display Panel

250 mL NDC: 78391-002-01

8 OZ CLORIGEL

HAND SANITIZER 
hypochlorous acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78391-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.0005 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EDETIC ACID (UNII: 9G34HU7RV0) 0.05 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 1.2 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78391-002-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/30/2020
Labeler - Kepter Mexico S.A de C.V (812889284)
Establishment
NameAddressID/FEIBusiness Operations
Kepter Mexico S.A de C.V812889284manufacture(78391-002)

Revised: 5/2020
Document Id: a6e97b55-256c-0e3b-e053-2a95a90aae30
Set id: a6ea3096-b140-5494-e053-2a95a90a5042
Version: 1
Effective Time: 20200530
 
Kepter Mexico S.A de C.V