62% GEL HAND SANITIZER- alcohol gel 
CBIO Brand Distribution International 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.

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Sanigenix 62% Gel Hand Sanitizer

Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To help reduce bacteria on skin.

Warnings

For external use only. Flammable, keep away from source of heat & fire.

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use & ask doctor if irritation occurs or redness develops & persists.

Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.

Directions

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children
under 5 should be supervised using this product.

Inactive ingredients

Water (Aqua, Eau), Glycerin, Liquid Preneutralized Thickener/Emulsifier, Squalane, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

Package Label - Principal Display Panel

SGX 62% Gel 1L1L NDC: 78044-400-05

62% GEL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78044-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
SQUALANE (UNII: GW89575KF9)  
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78044-400-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/17/2020
Labeler - CBIO Brand Distribution International Inc. (117495482)
Registrant - CBIO Brand Distribution International Inc. (117495482)

Revised: 8/2020
Document Id: ad1d6e38-b824-06ed-e053-2995a90a1cca
Set id: ad1ebb3b-6126-1e53-e053-2a95a90a40b0
Version: 1
Effective Time: 20200817
 
CBIO Brand Distribution International Inc.