SIERRA SOFT ANTIBACTERIAL WASH- chloroxylenol liquid
CWGC LA 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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CWGC (as PLD) - Sierra Soft Antibacterial Wash Foam (70415-001)

Drug Facts

Active ingredient

Chloroxylenol, 0.5%

Purpose

Antibacterial

Uses

For handwashing to reduce bacteria on the skin

Warnings

For external use only

When using this product

avoid contact with eyes. In case of eye contact, flush with water

Keep out of reach of children.

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

Directions

Apply foaming cleanser to dry hands
Rub hands together to spread lather
Wash for 15-20 seconds
Rinse & dry hands thoroughly

Inactive ingredients

Water, Sodium Laureth Sulfate, Isopropyl Alcohol, Cocamidopropyl Betaine, Decyl Glucoside, SODIUM C14-16 OLEFIN SULFONATE, Hydrogenated castor Oil, DMDM Hydantoin, Citric Acid, Fragrance, FD&C Yellow No. 5, FD&C Red No. 4.

Package Labeling:

Label

SIERRA SOFT ANTIBACTERIAL WASH
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70415-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	5 g in 1 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70415-001-01	1 L in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/01/2016

Labeler - CWGC LA Inc. (034967904)