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

Bottle

Package Labeling:237ml

Bottle2

Package Labeling:500ml

Bottle3

Package Labeling:1000ml

Bottle4

BSAFE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79130-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79130-000-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/202010/23/2022
2NDC: 79130-000-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/202010/23/2022
3NDC: 79130-000-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/202008/29/2022
4NDC: 79130-000-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/202010/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/20/202010/23/2022
Labeler - Original Gourmet Food Company (164757184)

Revised: 3/2023