DEODORANT - triclocarban soap
Shanghai Kangyi Tourism Products 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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MegaFresh Deodorant Soap

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.

label

DEODORANT
triclocarban soap

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOCARBAN (TRICLOCARBAN)	TRICLOCARBAN	0.29 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER
Sodium Palmate
Sodium Cocoate
Calcium Carbonate
Glycerin
Sodium Chloride
Edetate Sodium
Etidronic Acid
Titanium Dioxide

#	Item Code	Package Description
Packaging
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

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

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

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

Revised: 11/2012

Document Id: d82ff015-abc5-4beb-bd97-3c34f9e377e2

Set id: 6695970f-b333-41e0-86c1-f18b4bfe72ad

Version: 3

Effective Time: 20121128

Shanghai Kangyi Tourism Products Co., Ltd.