RAGGEDY ANN AND ANDY FOAM- benzalkonium chloride soap

Raggedy Ann and Andy Foam by

Drug Labeling and Warnings

Raggedy Ann and Andy Foam 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

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)

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75878-003-75	221 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)