CLEAN SEPT ALCOHOL ANTISEPTIC 70% - TOPICAL HAND SANITIZER NON-STERILE GEL- ethyl alcohol gel 
BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA

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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NO CHANGES NOTIFICATION

Drug Facts Panel - Active Ingredients

Denatured Ethyl Alcohol 70% v/v. Purpose: Antiseptic.

Drug Facts Panel - Purpose

Purpose: Antiseptic.

Drug Facts Panel - Use

Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Drug Facts Panel - Warnings

For external use only. Flammable. Keep away from heat or flame.
Do not use
● in children less than 2 months of age
● on open skin wounds
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.

Do not use
● in children less than 2 months of age
● on open skin wounds

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.

Drug Facts Panel - Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Drug Facts Panel - Other Information

Store between 15-30 °C (59-86 °F)
Avoid freezing and excessive heat above 40 °C (104 °F)

Drug Facts Panel - Inactive Ingredients

Carbomer, Glycerin, Triethanolamine, Water.

Package Label - Principal Display Panel

200 ml, NDC 79916-001-01

Label Gel 200 ml

500 ml, NDC 79916-001-02

Label Gel 500 ml

1500 ml, NDC 79916-001-03

Label Gel 1500 ml

5000 ml, NDC 79916-001-04

Label Gel 5000 ml

3 ml, NDC 79916-001-05

Label Gel 3 ml

CLEAN SEPT ALCOHOL ANTISEPTIC 70% - TOPICAL HAND SANITIZER NON-STERILE GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79916-001
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
TROLAMINE (UNII: 9O3K93S3TK) 0.18 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.22 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) 0.6 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79916-001-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product08/06/2020
2NDC:79916-001-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/06/2020
3NDC:79916-001-031500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/06/2020
4NDC:79916-001-045000 mL in 1 JUG; Type 0: Not a Combination Product08/06/2020
5NDC:79916-001-053 mL in 1 POUCH; Type 0: Not a Combination Product08/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/06/2020
Labeler - BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA (900786538)
Establishment
NameAddressID/FEIBusiness Operations
BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA900786538manufacture(79916-001) , pack(79916-001) , label(79916-001)

Revised: 12/2020
Document Id: b5e13221-4228-5f08-e053-2995a90a1f9f
Set id: ac0e6e22-e798-3789-e053-2995a90a0411
Version: 2
Effective Time: 20201207
 
BE FACTORY LABORATORIES INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO LTDA