CANDY APPLE ANTI BACTERIAL HAND SANITIZER  - benzethonium chloride liquid 
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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 Fact

Active Ingredient

Benzethonium Chloride 0.13%

Purpose

Antiseptic

Uses

To decrease bacteria on the skin

For external use only

When using this product: Keep out of eyes. Do not ingest.


Stop use and ask a doctor if skin irritation develops

Keep out of reach of children. If swallowed, get medical assistance.

Directions

Other Information:

Inactive Ingredient:

Deionized Water, Carbomer, Triehtanolamine, PEG-40 Hydrogenated Castor Oil, Fragrance, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

lablabel

CANDY APPLE ANTI BACTERIAL HAND SANITIZER  
benzethonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59021-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 82 g  in 100 mL
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59021-010-01225 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/12/2013
Labeler - Five Below (095446659)
Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture(59021-010)

Revised: 4/2013
Document Id: b5938a42-57de-40da-a966-9c89ec3e5b0b
Set id: 73d79b21-17b2-4d55-aab8-e313bd35055e
Version: 1
Effective Time: 20130412
 
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