RAGGEDY ANN AND ANDY TROPICAL BREEZE- triclosan soap
My Habitat Brands LLC

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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Raggedy
Ann&Andy™
Tropical Breeze
ANTIBACTERIAL
HAND SOAP

Drug Facts

Active Ingredient

Triclosan 0.2%

Purpose

Antibacterial

Uses

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

Warnings

For external use only.

When using this product, keep out of eyes. In case of contact with eyes, immediately flush eyes with water. Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse. Recommended for repeated use.

Inactive Ingredients

Water, Sodium Lauryl Ether Sulfate,Cocamide DEA,Cocamidopropyl Betaine, Sodium Chloride, Disodium EDTA, Citric Acid,Fragrance, Methylchloroisothiazolinone and Methylisothiazolinone

PRINCIPAL DISPLAY PANEL - 300ml Bottle Label

Raggedy
Ann&Andy™

Tropical Breeze
ANTIBACTERIAL
HAND SOAP

10.1 FL OZ
(300ml)

Principal Display Panel - 300ml Bottle Label

RAGGEDY ANN AND ANDY TROPICAL BREEZE
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75878-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	0.002 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
sodium lauryl sulfate (UNII: 368GB5141J)
Coco Diethanolamide (UNII: 92005F972D)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
sodium chloride (UNII: 451W47IQ8X)
edetate disodium (UNII: 7FLD91C86K)
citric acid monohydrate (UNII: 2968PHW8QP)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
methylisothiazolinone (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75878-002-30	300 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/20/2010

Labeler - My Habitat Brands LLC (965398246)

Raggedy Ann&Andy™ Tropical Breeze ANTIBACTERIAL HAND SOAP