MEGAFRESH ANTIBACTERIAL DEODORANT- triclocarban soap
American Amenities, Inc.

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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Active Ingredient: Triclocarban (0.3%)

Purpose: Antibacterial

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

For external use only. Keep out of reach of children

Children should use only this product under adults 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

Lather on wet skin and rinse well. Recommended for repeated use

Palm Oil, Water, Palm Kernel Oil, Sodium Chloride, Titanium Dioxide, Edetic Acid, Fragrance

label

MEGAFRESH ANTIBACTERIAL DEODORANT
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54157-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)	TRICLOCARBAN	0.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PALM OIL (UNII: 5QUO05548Z)
PALM KERNEL OIL (UNII: B0S90M0233)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETIC ACID (UNII: 9G34HU7RV0)

Product Characteristics
Color	white	Score	no score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:54157-101-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:54157-101-02	13 g in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:54157-101-03	20 g in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:54157-101-04	25 g in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC:54157-101-05	30 g in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC:54157-101-06	35 g in 1 PACKAGE; Type 0: Not a Combination Product
7	NDC:54157-101-07	42.5 g in 1 PACKAGE; Type 0: Not a Combination Product
8	NDC:54157-101-08	54 g in 1 PACKAGE; Type 0: Not a Combination Product
9	NDC:54157-101-09	60 g in 1 PACKAGE; Type 0: Not a Combination Product
10	NDC:54157-101-10	70 g in 1 PACKAGE; Type 0: Not a Combination Product
11	NDC:54157-101-11	75 g in 1 PACKAGE; Type 0: Not a Combination Product
12	NDC:54157-101-12	85 g in 1 PACKAGE; 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	part333A	03/04/2013

Labeler - American Amenities, Inc. (181454026)

Registrant - American Amenities, Inc. (181454026)