MOUSSE NON-RINSE HAND SANITIZER(FRAGRANCE FREE / GRAPEFRUIT)- benzalkonium chloride gel
Hangzhou Guoguang Touring Commodity Co., Ltd.

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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61312-011 Mousse Non-rinse Hand Sanitizer(Fragrance Free / Grapefruit)

Active Ingredient

BENZALKONIUM CHLORIDE 0.1%

Purpose

Antimicrobial

Use

Hand sanitizer to help decrease bacteria on the skin.

when water,soap &towel are note available.

recommended for repeated use.

Warning

For external use only

Flammable

Keep away from fire or flame

Do not apply around eyes,do not use in ears&mouth.

when using this product,avoid contact with eyes,

In case of contact flush eyes with water

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hour

Keep out of reach of children ,children must be supervised in use of this product.

Directions

pump as needed into your palms and thoroughly spread on both hands,rub into skin until dry.

INACTIVE INGREDIENT

Water,Glycerin,Aloe Barbadensis Leaf Juice, Carbomer,Fragrance,Triethanolamine,Tocopheryl Acetate,

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MOUSSE NON-RINSE HAND SANITIZER(FRAGRANCE FREE / GRAPEFRUIT)
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61312-011
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 g

Ingredient Name	Strength
Inactive Ingredients
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61312-011-02	8 in 1 CARTON	10/23/2016
1		250 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:61312-011-01	36 in 1 CARTON	10/23/2016
2		50 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/11/2016

Labeler - Hangzhou Guoguang Touring Commodity Co., Ltd. (526890634)

Name	Address	ID/FEI	Business Operations
Establishment
Hangzhou Guoguang Touring Commodity Co., Ltd.		526890634	manufacture(61312-011)