CANDY APPLE ANTI BACTERIAL FOAMING HAND - triclosan 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

Triclsan 0.3%

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, Sodium Laurel Sulfate, Cocamide MEA, Fragrance, Citric Acid, Disodium EDTA, Methylisothiazolinone, Methylchloroisothiazolinone, 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 FOAMING HAND 
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59021-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 82.009948 g  in 100 mL
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
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)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59021-001-01225 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(59021-001)

Revised: 4/2013
Document Id: 87785124-51ce-40fb-aedd-192bf9c6db9a
Set id: 4ad458ed-cf6c-462b-9a25-463f5f8f3d48
Version: 1
Effective Time: 20130412
 
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