BODY PRESCRIPTIONS ALOHA 65 PERCENT ALCOHOL 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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50563-413/JAS21SA5

Active Ingredient

Alcohol: 65% (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. If swallowed, get medical help or contact a poison control center right away at 1-800-222-1222

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

Not tested on animals

For adult use only

Inactive ingredients

Blue 1, Carbomer, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Triehtanolamine, Water, Yellow 5

image description

BODY PRESCRIPTIONS ALOHA 65 PERCENT ALCOHOL ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-413
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 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)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-413-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/18/2021
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-413)

Revised: 1/2021
Document Id: b943eb5a-acb2-638c-e053-2a95a90a5db5
Set id: 94820785-cef1-4024-9da0-c4faa6c44357
Version: 1
Effective Time: 20210119
 
ENCHANTE ACCESSORIES INC.