RAGGEDY ANN AND ANDY- triclosan soap

Raggedy Ann and Andy by

Drug Labeling and Warnings

Raggedy Ann and Andy by is a Otc medication manufactured, distributed, or labeled by My Habitat Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - My Habitat Brands LLC (965398246)