CRAYOLA HAND SANITIZING FOAM - benzalkonium chloride spray
Health-Tech, Inc.

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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Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

Decrease bacteria on skin

Warnings

For external use only
keep out of reach of children except under adult supervision
If swallowed, get medical help or contact a Poison Control Center right away.
Do not use in eyes.
Discontinue use if irritation or redness develop. If condition persists consult a doctor.

Directions

Turn pump heads to open position and push down
Wet palms of hands thoroughly with product
Wipe hands and face and then allow skin to dry

Inactive Ingredients

Cetrimonium chloride, D and C Green 5, D and C Red 33, FD and C Yellow 5, Disodium EDTA, DI water, Fragrance

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CRAYOLA HAND SANITIZING FOAM
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48871-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y)	benzalkonium chloride	.0013 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
cetrimonium chloride (UNII: UC9PE95IBP)
edetate disodium (UNII: 7FLD91C86K)
water (UNII: 059QF0KO0R)

Product Characteristics
Color	green (D and C green 5) , red (D and C red 33) , yellow (FD and C yellow 5)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:48871-005-01	12 in 1 CASE
1		9 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	09/01/2010

Labeler - Health-Tech, Inc. (084007889)

Name	Address	ID/FEI	Business Operations
Establishment
Health-Tech, Inc.		084007889	manufacture