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Creamsicle Hand Sanitizer by ENCHANTE ACCESSORIES INC.

Dosage form: liquid
Ingredients: ALCOHOL 62mL in 100mL
Labeler: ENCHANTE ACCESSORIES INC.
NDC Code: 50563-185

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

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

For external use only-hands

Flammable. Keep away from heat and flame

Keep out of eyes. In case of comtact 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 immediately.

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:

Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, 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.

CREAMSICLE HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-185
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  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 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
Packaging
#Item CodePackage Description
1NDC:50563-185-0129 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/02/2014
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
Establishment
NameAddressID/FEIOperations
Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture(50563-185)

Revised: 10/2014
 
ENCHANTE ACCESSORIES INC.

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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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