SIERRA SOFT NON-ALCOHOL FOAM SANITIZER- benzalkonium chloride gel
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.

----------

CWGC (as PLD) - SIERRA SOFT NON-ALCOHOL FOAM HAND SANITIZER (70415-103)

Active ingredient

BENZALKONIUM CHLORIDE 0.13%

Purpose

Antibacterial

Uses

For sanitizing to reduce bacteria on the skin.

Warnings

For external use only

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

Directions

TO USE, SIMPLY PLACE CARTRIDGE INTO DISPENSER AND USE STRAIGHT; DO NOT DILUTE. APPLY 1 PUMP OF SANITIZER ONTO HANDS AND RUB INTO SKIN. NO RINSING REQUIRED.

Inactive ingredients

Water, Propylene Glycol, Cocamidopropyl Betaine, Cocamine Oxide, Disodium EDTA, DMDM Hydantoin, Triethanolamine, Fragrance, FD&C Yellow No.5, FD&C Blue No.1.

Sierra Soft_Non-Alcohol Foam Sanitizer_SL_1L

Sierra Soft_Non-Alcohol Foam Sanitizer_SL_42oz

SIERRA SOFT NON-ALCOHOL FOAM SANITIZER
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70415-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70415-103-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2016
2	NDC:70415-103-12	1250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2016

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)