HAND THERAPE SANITIZER- benzethonium chloride gel

HAND THERAPE SANITIZER by

Drug Labeling and Warnings

HAND THERAPE SANITIZER by is a Otc medication manufactured, distributed, or labeled by PHARMAGEL INTERNATIONAL INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Benzethonium Chloride 0.2%

PURPOSE

Antimicrobial

USES

Hand sanitizer to decrease bacteria on skin. Suitable for repeated use.

WARNINGS

For external use only

When using this product:

avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.

if irritation or redness occurs to skin, discontinue use.

if condition continues, consult a physician.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

Apply product thoroughly, rubbing hands together briskly until absorbed. Apply as needed. Store at room temperature.

INACTIVE INGREDIENTS:

WATER (AQUA), CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, PEG-100 STEARATE, GLYCERYL STEARATE, CYCLOPENTASILOXANE, STEARIC ACID, GLYCERIN, DIMETHICONE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, BUTYROSPERMUM PARKII (SHEA BUTTER), CETYL ALCOHOL, PHENOXYETHANOL, TRIETHANOLAMINE, PROPYLENE GLYCOL, CARBOMER, STEARYL ALCOHOL, PEG-7 GLYCERYL COCOATE, CAPRYLYL GLYCOL, POLYSORBATE 40, TOCOPHEROL, ETHYLHEXYLGLYCERIN, SODIUM PCA, BHT, PANTHENOL, HEXYLENE GLYCOL, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, BUTYLENE GLYCOL, RETINYL PALMITATE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, MAGNESIUM ASCORBYL PHOSPHATE, ETHYLHEXYL METHOXYCINNAMATE, UNDECYLENOYL PHENYLALANINE, BUTYL METHOXYDIBENZOYLMETHANE, CAMELLIA SINENSIS(GREEN TEA) LEAF EXTRACT, POLYSORBATE 20, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, FRAGRANCE (PARFUM)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND THERAPE SANITIZER 
benzethonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67879-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SAFFLOWER OIL (UNII: 65UEH262IS)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
JOJOBA OIL (UNII: 724GKU717M)
SHEANUT OIL (UNII: O88E196QRF)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYSORBATE 40 (UNII: STI11B5A2X)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PANTHENOL (UNII: WV9CM0O67Z)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
OCTINOXATE (UNII: 4Y5P7MUD51)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)
AVOBENZONE (UNII: G63QQF2NOX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67879-201-13	88 mL in 1 TUBE; Type 0: Not a Combination Product	06/18/2015
2	NDC: 67879-201-16	175 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/18/2015
3	NDC: 67879-201-26	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/18/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/18/2015

Labeler - PHARMAGEL INTERNATIONAL INC (603215182)

Registrant - PHARMAGEL INTERNATIONAL INC (603215182)