APRIL BATH AND SHOWER CUCUMBER MELON SCENTED HAND SANITIZER ANTI-BACTERIAL - chloroxylenol liquid 
ENCHANTE ACCESSORIES 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 Fact

Active Ingredient

Chloroxylenol  0.5%

Purpose

Antiseptic

Uses

To decrease bacteria on the skin that could cause diseases

Recommended for repeated use

For external use only

Flammable

When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water.  Avoid Contact with broken skin. Do not inhale or ingest.


Stop use and ask a doctor if skin irritation develops

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away

Directions

Other Information:

Inactive Ingredient:

Benzethonium Chloride, Alcohol, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate, may contain D and C Red No. 33, D and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

labelabel

APRIL BATH AND SHOWER CUCUMBER MELON SCENTED HAND SANITIZER ANTI-BACTERIAL 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
TROLAMINE (UNII: 9O3K93S3TK)  
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)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-113-01236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/18/2012
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture

Revised: 6/2012
Document Id: 838a9bbf-ef6e-44cc-ab60-37a2a27d7c85
Set id: 1352dc4d-e939-4a7f-95c6-3fbabca3f55c
Version: 1
Effective Time: 20120628
 
ENCHANTE ACCESSORIES INC.