CRAYOLA SUNGLOW YELLOW ROLL ON HAND SANITIZER - benzalkonium chloride gel 
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 Ingredients

Active Ingredients: Benzalkonium Chloride - 0.13%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on skin

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 the eyes. Discontinue use if irritation or redness develops. If condition persists, consult a doctor.


Directions

Remove cap. roll over palms and fingers to wet hands thoroughly. Allow to dry without wiping.

Aloe, Vera, Cetrimonium Chloride, Citrus Fragrance, Disodium EDTA, D and C red 33, FD and C yellow 5, Luvigel, Water

Crayola Sun Glow Yellow roll on label

MM20Crayola Sun glow yellow label

Crayola blister card

MM21Crayola card

Crayola roll on shipper label

MM17Crayola roll on shipper label

CRAYOLA SUNGLOW YELLOW ROLL ON HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride.0013 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aloe vera leaf (UNII: ZY81Z83H0X)  
Cetrimonium Chloride (UNII: UC9PE95IBP)  
Edetate Disodium (UNII: 7FLD91C86K)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (FD and C Yellow 5) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48871-009-014 in 1 CASE
16 in 1 CARTON
11 in 1 BLISTER PACK
120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33309/01/2010
Labeler - Health-Tech, Inc. (084007889)
Establishment
NameAddressID/FEIBusiness Operations
Health-Tech, Inc.084007889manufacture

Revised: 5/2010
Document Id: 18387bfe-dc5b-490e-9a4d-ecc425ac74f4
Set id: f803e3ca-39d0-4517-bffe-afdc8773c6b7
Version: 2
Effective Time: 20100525
 
Health-Tech, Inc.