80% 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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Gel Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Gel 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

SGX80 Gel 60 mLSGX80 Gel 100 mLSGX80 Gel 250 mLSGX80 Gel 500 mLSGX80 Gel 1 GallonSGX80 Gel 55 GallonSGX80 Gel 265 Gallon60 mL NDC: 78044-200-07

100 mL NDC: 78044-200-01

250 mL NDC: 78044-200-02

500 mL NDC: 78044-200-03

3.785 L NDC: 78044-200-04

208.198 L NDC: 78044-200-05

1003.13 L NDC: 78044-200-06

80% GEL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78044-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78044-200-01100 mL in 1 TUBE; Type 0: Not a Combination Product05/27/2020
2NDC:78044-200-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
3NDC:78044-200-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
4NDC:78044-200-043785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
5NDC:78044-200-05208198 mL in 1 DRUM; Type 0: Not a Combination Product05/27/2020
6NDC:78044-200-061003130 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product05/27/2020
7NDC:78044-200-0760 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/27/2020
Labeler - CBIO Brand Distribution International Inc. (117495482)
Registrant - CBIO Brand Distribution International Inc. (117495482)

Revised: 6/2020
Document Id: a7b23795-bbfd-250c-e053-2995a90abb0b
Set id: a7b25805-0466-6dc0-e053-2a95a90a0ed4
Version: 1
Effective Time: 20200609
 
CBIO Brand Distribution International Inc.