MOISTURIZING HAND SANITIZER- benzethonium chloride lotion

Moisturizing Hand Sanitizer by

Drug Labeling and Warnings

Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzethonium chloride 0.2%

Purpose

Antimicrobial

Uses

• to decrease bacteria on the skin that could cause disease
• recommended for repeated use

Warnings

For external use only - hands only

When using this product

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• avoid contact with broken skin

Keep out of reach of children.

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

Directions

• wet hands thoroughly with product
• briskly rub hands together until absorbed
• apply to hands as needed
• for children under 6, use only under adult supervision
• not recommended for infants

Inactive ingredients

water, dimethicone, cetyl alcohol, cyclopentasiloxane, stearyl alcohol, polyquaternium-37, cocamidopropyl PG-dimonium chloride phosphate, glyceryl laurate, butylene glycol, Vitis vinifera (grape) seed oil, tocopheryl acetate, Butyrospermum parkii (shea) butter extract, Chamomilla recutita (matricaria) flower extract, Aloe barbadensis leaf juice, Camellia oleifera leaf extract, Thymus vulgaris (thyme) flower/leaf oil, Melaleuca alternifolia (tea tree) leaf oil, Litsea cubeba fruit oil, Origanum vulgare oil, cholecalciferol, ascorbic acid, retinyl palmitate, glycerin, glyceryl caprylate/caprate, propylene glycol, glyceryl stearate SE, steareth-2, steareth-21, polysorbate 20, beeswax, ethylhexylglycerin, ethylhexyl palmitate, tetrasodium EDTA, phenoxyethanol, methylparaben, ethylparaben, imidazolidinyl urea, DMDM hydantoin, potassium sorbate, sodium benzoate, citric acid

Rear label text

*Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds

Distributed By: Vi-Jon, Inc.

8515 Page Ave

St. Louis, MO 63114

www.germx.com

478.001 478AA rev 1

princpal display panel

germ-X Moisturizing Hand Sanitizer Lotion

2 in 1 moisturize & sanitize hands

KILLS 99.99% OF GERMS

Fragrance Free

Alcohol Free

Dermatologist Tested

NET WT 2 OZ (59 g)

INGREDIENTS AND APPEARANCE

MOISTURIZING HAND SANITIZER 
benzethonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-478
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	1.98 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
GLYCERYL LAURATE (UNII: Y98611C087)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GRAPE SEED OIL (UNII: 930MLC8XGG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEA BUTTER (UNII: K49155WL9Y)
CHAMOMILE (UNII: FGL3685T2X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
THYME OIL (UNII: 2UK410MY6B)
TEA LEAF OIL (UNII: VC855RRT77)
LITSEA CUBEBA FRUIT (UNII: R3617MQA5Z)
LITSEA OIL (UNII: 2XIW34BN6O)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
GLYCERIN (UNII: PDC6A3C0OX)
glyceryl caprylate/caprate (UNII: G7515SW10N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARETH-2 (UNII: V56DFE46J5)
Steareth-21 (UNII: 53J3F32P58)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
YELLOW WAX (UNII: 2ZA36H0S2V)
Ethylhexylglycerin (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
EDETATE SODIUM (UNII: MP1J8420LU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
IMIDUREA (UNII: M629807ATL)
DMDM HYDANTOIN (UNII: BYR0546TOW)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-478-16	56 g in 1 TUBE; Type 0: Not a Combination Product	05/03/2016
2	NDC: 11344-478-26	113 g in 1 TUBE; Type 0: Not a Combination Product	05/03/2016
3	NDC: 11344-478-32	340 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/03/2016

Labeler - Vi-Jon, Inc (150931459)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		088520668	manufacture(11344-478)