PEPPERMINT SWIRL ANTIBACTERIAL HAND SANITIZER - ethyl alcohol liquid 
Enchante Accessories

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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PEPPERMINT SWIRL SCENTED ANTIBACTERIAL HAND SANITIZER

DRUG FACTS

Active Ingredients                        Purpose

Ethyl Alcohol 62%                        Antiseptic

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use.

Warnings:

For external use only-hands.

Flammable

Keep away from heat and flame.

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 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 105 degrees F

May discolor some fabrics

Harmful to wood finishes and plastics.

Inactive ingredients

Ingredients/ingredients: water (aqua), glycerin, trethanolamine, carbomer, fragrance (parfum), PEG-40, hydrogenated castor oil, DMCM Hydantoin, hydrogenated jojoba oil, FD and C blue No1, FD and C yellow No 5, FD and C red40

Formulated exclusively and distributed by:
Enchante Accessories, Inc.
New York, NY 10016
Not Tested On Animals. For adult use only.
Designed in the USA
Made in China
3.1 fl oz/90 ml

Peppermint Swirl

scented

Antibacterial

Hand Sanitizer

3.1 fl. oz. / 90ml

handsanitizerlabel

handsanitizerdrugpanel

PEPPERMINT SWIRL ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
JOJOBA OIL (UNII: 724GKU717M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-303-0190 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33307/07/2010
Labeler - Enchante Accessories (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Blue Dream Cosmetic Co., Ltd.529047234manufacture

Revised: 7/2010
Document Id: 0563acc8-bcbd-4b2c-a92e-e8b4fd53b929
Set id: 001f1a44-efb3-4ac3-9389-0809fb901194
Version: 3
Effective Time: 20100709
 
Enchante Accessories