BODY PRESCRIPTIONS WINTER MINT ANTIBACTERIAL HAND SANITIZER- ethyl alcohol solution 
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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50563-271/ G0XAHS09/G0XAHS11/G0XAHS14

Active Ingredient

Alcohol: 75% (v/v)

Purpose

Antiseptic

Use

■ To decrease bacteria on the skin that could cause disease
■Recommended for repeated use

WARNINGS

For external use only

Flammable. Keep away from heat or flame

Do not use

in children less than two months of age

on open skin wounds

When using this product, keep out of eyes, ears, and mouth 
In case of contact with eyes, rinse eyes thoroughly with water

Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away at 1-800-222-1222

Directions

Place enough product on hands to cover all surfaces. Rub hands together untill dry.

Supervise children under six years of age when using this product to avoid swallowing

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Carbomer, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Triehtanolamine, Water

image description

BODY PRESCRIPTIONS WINTER MINT ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-271
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-271-01355 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/30/2020
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-271)

Revised: 10/2020
Document Id: b0a126af-2643-ef2e-e053-2995a90aa3ea
Set id: cac11565-05e4-4736-ab84-79256011a7f0
Version: 1
Effective Time: 20201001
 
ENCHANTE ACCESSORIES INC.