CANDY APPLE  - ethyl alcohol gel 
Shanghai Weierya Daily Chemicals Factory

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

Inactive Ingredients

carbomer 940, PEG-12

dimethicone, tocopheryl

acetate, triethanomaline,

blue 1, water

Active Ingredient

Ethyl Alcohol, 65 % v/v

Purpose  Antimicrobial

Uses

hand sanitizer to help

reduce bacteria on skin

Do not use in or near the eyes.

In case of contact, rinse eyes

thoroughly with water.

Stop use and ask a doctor if

irritation, excessive redness

or rash develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison

Control Center right away.

Directions

Put a dime sized drop onto hands

and rub together briskly until dry.

Other information

Store below 110 F (43 C)

Warning

For external use only


Flammable, keep away from fire or flame.

copy of label

CANDY APPLE  
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLE (candy apple) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58194-012-0129 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2014
Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-012)

Revised: 6/2014
Document Id: 467a7139-66fa-4620-985b-ab8c3a7511fa
Set id: e7c92861-8740-4ad7-aa9f-d0851d4c1fab
Version: 1
Effective Time: 20140604
 
Shanghai Weierya Daily Chemicals Factory