PRIME- benzalkonium chloride soap
Prime Industries Usa, Inc

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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Active Ingredient

Benzalkonium chloride 0.13% w/v

Purpose

Antibacterial

Use

For handwashing to decrease bacteria on the skin

Warnings

For external use only

When using this product, avoid contact with eyes. In case of contact with eyes, flush with water.

Stop use and ask a doctor if irritation or redness develops.

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

Directions

Pump into hands & wet as needed. Lather vigorously for at least 20 seconds. Wash skin, rinse thoroughly and dry

Inactive ingredients

Water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.

Package Label - Principal Display Panel

Label 1

Label 2

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PRIME
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79382-002
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
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79382-002-01	332 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2020
2	NDC:79382-002-02	400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2020
3	NDC:79382-002-03	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2020
4	NDC:79382-002-04	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2020
5	NDC:79382-002-05	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2020
6	NDC:79382-002-06	100000 mL in 1 DRUM; Type 0: Not a Combination Product	08/04/2020
7	NDC:79382-002-07	200000 mL in 1 DRUM; Type 0: Not a Combination Product	08/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/04/2020

Labeler - Prime Industries Usa, Inc (117547551)