BSAFE ANTIBACTERIAL DISSOLVING SHEETS- benzalkonium chloride film, soluble
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.

----------

BSafe Antibacterial Dissolving Soap 15 Sheets

Drug Facts

Active ingredient

Benzalkonium Chloride 0.10%

Purpose

Antibacterial

Uses

for washing to decrease bacteria on the skin that potentially can cause disease

Warnings

For external use only

When using this product

keep out of eyes
in case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash occurs.

Keep out of reach of children.

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

Directions

place a soap sheet in palm of hand, add water, lather for 15 seconds, rinse and dry
do not use on infants under 6 months of age

Other information

store between 15-30 °C (59-86 °F)

Inactive ingredients:

water, corn starch, polyvinyl alcohol, sodium lauryl sulfate, cocamidopropyl betaine, sodium laureth sulfate, aloe barbadensis leaf juice powder, mineral oil, sodium polyacrylate, ethylhexylglycerin, phenoxyethanol, fragrance.

Questions?

call 1-888-761-8399

Package Labeling:

Bottle

BSAFE ANTIBACTERIAL DISSOLVING SHEETS
benzalkonium chloride film, soluble

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79130-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79130-100-15	15 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/01/2020	10/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/01/2020	10/02/2020

Labeler - ORIGINAL GOURMET FOOD COMPANY (164757184)

Revised: 3/2023

Document Id: f792c569-d73a-a994-e053-6294a90a5331

Set id: b0f2d4dd-3861-4076-e053-2a95a90a6d9d

Version: 4

Effective Time: 20230323

ORIGINAL GOURMET FOOD COMPANY