DEODORANT- triclocarban soap

DEODORANT by

Drug Labeling and Warnings

DEODORANT by is a Otc medication manufactured, distributed, or labeled by Shanghai Kangyi Tourism Products Co., Ltd. , Shanghai Kangyi Tourism Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Triclocarban 0.29%

Antibacterial

Use

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

WARNINGS

For external use only. Keep out of reach of children.

Children should use only this product under adult supervision.

Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Avoid contact with broken skin.

When using this product, avoid contact with eyes. In case of eye contact, immediately flush eyes with water, call a doctor.

keep out of reach of children

Directions

Wet hands. Apply to hands. Scrub thoroughly. Rinse.

Recommended for repeated use.

Inactive ingredients

Sodium Palmate, Sodium Cocoate, Calcium Carbonate, Water, Glycerin, Fragrance, Sodium Chloride, Edetate Sodium, Etidronic Acid, Titanium Dioxide.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEODORANT  
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53507-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)	TRICLOCARBAN	0.29 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Sodium Palmate (UNII: S0A6004K3Z)
Sodium Cocoate (UNII: R1TQH25F4I)
Calcium Carbonate (UNII: H0G9379FGK)
Glycerin (UNII: PDC6A3C0OX)
Sodium Chloride (UNII: 451W47IQ8X)
Edetate Sodium (UNII: MP1J8420LU)
Etidronic Acid (UNII: M2F465ROXU)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53507-001-01	10 g in 1 PACKAGE
2	NDC: 53507-001-02	13 g in 1 PACKAGE
3	NDC: 53507-001-03	20 g in 1 PACKAGE
4	NDC: 53507-001-04	30 g in 1 PACKAGE
5	NDC: 53507-001-05	35 g in 1 PACKAGE
6	NDC: 53507-001-06	54 g in 1 PACKAGE
7	NDC: 53507-001-07	60 g in 1 PACKAGE
8	NDC: 53507-001-08	75 g in 1 PACKAGE
9	NDC: 53507-001-09	85 g in 1 PACKAGE
10	NDC: 53507-001-10	14.17 g in 1 PACKAGE
11	NDC: 53507-001-11	21.26 g in 1 PACKAGE
12	NDC: 53507-001-12	28.35 g in 1 PACKAGE
13	NDC: 53507-001-13	42.52 g in 1 PACKAGE
14	NDC: 53507-001-14	71 g in 1 PACKAGE
15	NDC: 53507-001-15	99 g in 1 PACKAGE
16	NDC: 53507-001-16	113 g in 1 PACKAGE
17	NDC: 53507-001-17	142 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/24/2012

Labeler - Shanghai Kangyi Tourism Products Co., Ltd. (531054513)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Kangyi Tourism Products Co., Ltd.		531054513	manufacture(53507-001)