SIERRA SOFT NON-ALCOHOL FOAM HAND SANITIZER- benzalkonium chloride solution
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 Non-Alcohol Foam Hand Sanitizer (70415-106)

Active ingredient

BENZALKONIUM CHLORIDE 0.13%

Purpose

Antibacterial

Uses

For hand washing to reduce bacteria on the skin. Recommended for repeat use.

Warnings

For external use only.

Avoid contact with eyes - in case of contact, flush eyes with water.

Keep out of reach of children. If swallowed, get immediate medical attention.

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

Directions

Apply foam sanitizer to hands. Rub over surfaces of both hands for 15 seconds. No rinsing required.

Inactive ingredients

Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid, Fragrance.

Label1083-05NonAlcoholFoamSanizerPLTCC104-040119

SIERRA SOFT NON-ALCOHOL FOAM HAND SANITIZER
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70415-106
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCO GLUCOSIDE (UNII: ICS790225B)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70415-106-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2016
2	NDC:70415-106-21	18925 mL in 1 PAIL; Type 0: Not a Combination Product	10/04/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/04/2016

Labeler - CWGC LA Inc. (034967904)