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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54157-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOCARBAN (TRICLOCARBAN) TRICLOCARBAN0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PALM OIL 
PALM KERNEL OIL 
SODIUM CHLORIDE 
TITANIUM DIOXIDE 
EDETIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54157-101-0110 g in 1 PACKAGE
2NDC:54157-101-0213 g in 1 PACKAGE
3NDC:54157-101-0320 g in 1 PACKAGE
4NDC:54157-101-0425 g in 1 PACKAGE
5NDC:54157-101-0530 g in 1 PACKAGE
6NDC:54157-101-0635 g in 1 PACKAGE
7NDC:54157-101-0742.5 g in 1 PACKAGE
8NDC:54157-101-0854 g in 1 PACKAGE
9NDC:54157-101-0960 g in 1 PACKAGE
10NDC:54157-101-1070 g in 1 PACKAGE
11NDC:54157-101-1175 g in 1 PACKAGE
12NDC:54157-101-1285 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/04/2013
Labeler - American Amenities, Inc. (181454026)
Registrant - American Amenities, Inc. (181454026)
Establishment
NameAddressID/FEIBusiness Operations
American Amenities, Inc.181454026manufacture(54157-101)

Revised: 3/2013
Document Id: aa24120e-2711-4e51-ae20-c6ae96dadb79
Set id: 8ba6541f-bdab-4cc1-9123-519a5c47af1c
Version: 1
Effective Time: 20130307
 
American Amenities, Inc.