MEGAFRESH ANTIBACTERIAL DEODORANT- triclocarban soap

MegaFresh Antibacterial Deodorant by

Drug Labeling and Warnings

MegaFresh Antibacterial Deodorant by is a Otc medication manufactured, distributed, or labeled by American Amenities, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Triclocarban (0.3%)

PURPOSE

Purpose: Antibacterial

INDICATIONS & USAGE

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

WARNINGS

For external use only. Keep out of reach of children

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.

ASK DOCTOR

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEGAFRESH ANTIBACTERIAL DEODORANT 
triclocarban soap

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/04/2013

Labeler - American Amenities, Inc. (181454026)

Registrant - American Amenities, Inc. (181454026)