RAGGEDY ANN AND ANDY FOAM VANILLA BEAN- benzalkonium chloride 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™
FOAM HAND SOAP
Vanilla
Bean

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

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 palm full to hands. Scrub thoroughly. Rinse. Recommended for repeated use.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Glycerin, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate, FD&C Yellow No.5

PRINCIPAL DISPLAY PANEL - 221ml Bottle Label

Raggedy
Ann&Andy™

ANTIBACTERIAL
FORMULA Enriched
with Vitamin E

FOAM HAND SOAP

Vanilla
Bean

7.5 FL OZ (221ml)

Principal Display Panel - 221ml Bottle Label

RAGGEDY ANN AND ANDY FOAM VANILLA BEAN
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75878-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.0013 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Glycerin (UNII: PDC6A3C0OX)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Edetate Disodium (UNII: 7FLD91C86K)
FD&C Yellow No. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75878-003-75	221 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™ FOAM HAND SOAP Vanilla Bean