BROOKSTONE LEMON ZEST HYPOALLERGENIC ANTIBACTERIAL HAND- chloroxylenol soap
Argento sc by sicura 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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77731-093/AB0059LZ-YEL soap

Active Ingredient(s)

Chloroxylenol 0.2%

Purpose:

Antibacterial

Use

Decreases bacteria on skin that could cause diseases

Recommended for repeated use

Warnings

For external use on hands only.

When using this product

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water

Stop use and ask a doctor

if irrigation and redness develop or if condition persists for more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

Apply onto wet hands. Lather and rinse thoroughly

Other information

Store at room temperature

Inactive ingredients

Water, Sodium lauroamphoacetate, Sodium Chloride, Cocamide DEA, Citric acid, Phenoxyethanol, Fragrance, Disodium EDTA, Cocamidopropyl betaine, Yellow 5 (CI19140)

image description

BROOKSTONE LEMON ZEST HYPOALLERGENIC ANTIBACTERIAL HAND
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77731-093
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DISODIUM HEDTA (UNII: KME849MC7A)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77731-093-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/17/2020

Labeler - Argento sc by sicura inc. (168718778)