BSafe Hand Sanitizer by Original Gourmet Food Company BSafe Hand Sanitizer

BSafe Hand Sanitizer by

Drug Labeling and Warnings

BSafe Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Original Gourmet Food Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BSAFE HAND SANITIZER- alcohol gel 
Original Gourmet Food Company

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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BSafe Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 70% (v/v)

Purpose

Antiseptic

Uses

• helps reduce bacteria on hands that potentially can cause disease 
• for use when soap and water are not available.

Warnings

For external use only. Flammable, keep away from heat and flame.

Do not use

• on children less than 2 months of age 
• on open wounds

When using this product

• keep out of eyes, ears and mouth 
• in case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor 

if irritation or rash occurs. These may be a sign of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• place enough product on hands to cover all surfaces
• rub hands together until dry.
• for children under 6, use adult supervision.

Other information

• store between 15-30 °C (59-86 °F)
• avoid freezing and excessive heat about 40 °C (104 °F)

Inactive ingredients:

Water, Propylene Glycol, Carbomer, Triethanolamine, Allantoin, Aloe Barbadensis Leaf Juice Powder, Butylene Glycol, Artermisia Vulgaris Extract, Fragrance.

Package Labeling:60ml

Package Labeling:237ml

Package Labeling:500ml

Package Labeling:1000ml

BSAFE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79130-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79130-000-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2020	10/23/2022
2	NDC: 79130-000-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2020	10/23/2022
3	NDC: 79130-000-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2020	08/29/2022
4	NDC: 79130-000-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2020	10/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/20/2020	10/23/2022

Labeler - Original Gourmet Food Company (164757184)

Revised: 3/2023

Document Id: f794887f-6eec-1047-e053-6294a90ad8df

34390-5

Set id: a8fd5469-c9f2-46c1-e053-2995a90a53c6

Version: 3

Effective Time: 20230323