JABONITO FRESH- triclosan soap 
Industria LA Popular SA

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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PURPOSE

Antibacterial

For washing to decrease bacteria on the skin.

ACTIVE INGREDIENT

Triclosan 0.05%

WARNING

For external use only

WHEN USING THIS PRODUCT

Avoid contact with eyes. If contact occurs rinse thoroughly with water.

STOP USE and contact doctor if irritation and redness develops.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact poison control center right away.

DIRECTIONS

Wet bar with water.

Lather vigirously and wash skin.

Rinse and dry thoroughly.

INACTIVE INGREDIENTS

Titanium Dioxide
Water
Talc
Fragrance
Sodium Tallowate

FD & C Blue No.1

OTHER INFORMATION

Registro sanitario: Guatemala PT-66360

QUESTIONS?

1-801-0026-227

Dosage and Administration

Dosage and administration

label

JABONITO FRESH 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62476-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.0005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
TALC (UNII: 7SEV7J4R1U)  
ABRONIA FRAGRANS WHOLE (UNII: LXC8S3ELIE)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62476-100-014 g in 1 BOX; Type 0: Not a Combination Product01/26/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/26/2016
Labeler - Industria LA Popular SA (846044576)
Establishment
NameAddressID/FEIBusiness Operations
Industria LA Popular SA846044576manufacture(62476-100)

Revised: 2/2016
Document Id: 2be5226a-e36a-7495-e054-00144ff8d46c
Set id: 2a3fbb79-f896-6be1-e054-00144ff8d46c
Version: 4
Effective Time: 20160216
 
Industria LA Popular SA