BODY PRESCRIPTIONS ALOHA 65 PERCENT ALCOHOL ANTIBACTERIAL HAND SANITIZER- ethyl alcohol solution

BODY PRESCRIPTIONS Aloha 65 PERCENT ALCOHOL ANTIBACTERIAL HAND SANITIZER by

Drug Labeling and Warnings

BODY PRESCRIPTIONS Aloha 65 PERCENT ALCOHOL ANTIBACTERIAL HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC., Xiamen Afgamarine Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BODY PRESCRIPTIONS ALOHA 65 PERCENT ALCOHOL ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-413-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/18/2021

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Afgamarine Biotechnology Co., Ltd.		420485152	manufacture(50563-413)