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

Bottle

Package Labeling:237ml

Bottle2

Package Labeling:500ml

Bottle3

Package Labeling:1000ml

Bottle4

BSAFE HAND SANITIZER
alcohol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Version: 3

Effective Time: 20230323

Original Gourmet Food Company