Germs be Gone Antibacterial Hand Soap: Vanilla and Shea Butter

ANTIBACTERIAL VANILLA AND SHEA BUTTER- benzalkonium chloride liquid
Brands International Corporation

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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Benzalkonium Chloride - 0.13%

Purpose - Antiseptic Skin cleanser

Uses for handwashing or decrease bacteria to the skin

Warnings For external use only

Stop use and ask a doctor if irritation or redness develops

When using this product

do not get it into eyes. If contact occurs, rinse eye thoroughly with water

Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away

Directions

wet hands
apply palmful to hands
scrub thoroughly
rinse
For occasional and personal domestic use
Supervise children when they use this product.

Lauramidopropylamine oxide, lauryl glucoside, PEG-150 distearate, glycol stearate, perfume, PEG-7 glycerly cocoate, centrimonium chloride, Citric Acid, Glycerin, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone,

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ANTIBACTERIAL VANILLA AND SHEA BUTTER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50157-508
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCOL STEARATE (UNII: 0324G66D0E)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50157-508-23	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/10/2020
2	NDC:50157-508-37	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/10/2020
3	NDC:50157-508-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/10/2020
4	NDC:50157-508-44	443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/10/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/10/2020

Labeler - Brands International Corporation (243748238)