JABONITO FRESH- triclosan soap

Jabonito Fresh by

Drug Labeling and Warnings

Jabonito Fresh by is a Otc medication manufactured, distributed, or labeled by Industria LA Popular SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

PURPOSE

Antibacterial

For washing to decrease bacteria on the skin.

ACTIVE INGREDIENT

ACTIVE INGREDIENT

Triclosan 0.05%

WARNINGS

WARNING

For external use only

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

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

INSTRUCTIONS FOR USE

DIRECTIONS

Wet bar with water.

Lather vigirously and wash skin.

Rinse and dry thoroughly.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

Titanium Dioxide
Water
Talc
Fragrance
Sodium Tallowate

FD & C Blue No.1

OTHER SAFETY INFORMATION

OTHER INFORMATION

Registro sanitario: Guatemala PT-66360

QUESTIONS

QUESTIONS?

1-801-0026-227

Dosage and Administration

Dosage and administration

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JABONITO FRESH 
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62476-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.0005 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)
TALC (UNII: 7SEV7J4R1U)
ABRONIA FRAGRANS WHOLE (UNII: LXC8S3ELIE)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62476-100-01	4 g in 1 BOX; Type 0: Not a Combination Product	01/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/26/2016

Labeler - Industria LA Popular SA (846044576)

Establishment
Name	Address	ID/FEI	Business Operations
Industria LA Popular SA		846044576	manufacture(62476-100)