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.

----------

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 DEA Schedule     
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)

Revised: 5/2015
Document Id: e9611377-e62c-4801-a0f2-2a6e87b5af5b
Set id: 8ba6541f-bdab-4cc1-9123-519a5c47af1c
Version: 2
Effective Time: 20150530
 
American Amenities, Inc.