April Bath and Shower Sweet Blossom Scented Hand Sanitizer Anti-Bacterial

Dosage form: liquid
Ingredients: CHLOROXYLENOL 0.5g in 100mL
Labeler: ENCHANTE ACCESSORIES INC.
NDC Code: 50563-114

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.

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

  • Wet hands thoroughly with product and allow to dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommended for infants

Other Information:

  • Do not store above 105F
  • May discolor some fabrics
  • Harmful to wood finishes and plastics

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.

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APRIL BATH AND SHOWER SWEET BLOSSOM SCENTED HAND SANITIZER ANTI-BACTERIAL 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-114
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER COPOLYMER TYPE A 
TROLAMINE 
EDETATE DISODIUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
ALCOHOL 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
BENZETHONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:50563-114-01236 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/FEIOperations
Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture

Revised: 06/2012
 
ENCHANTE ACCESSORIES INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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