PRIME- benzalkonium chloride soap

Prime by

Drug Labeling and Warnings

Prime by is a Otc medication manufactured, distributed, or labeled by Prime Industries Usa, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

PRIME 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79382-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/04/2020

Labeler - Prime Industries Usa, Inc (117547551)