BODY PRESCRIPTIONS ROSE 65 PERCENT ALCOHOL ANTIBACTERIAL HAND SANITIZER: Package Insert and Label Information

BODY PRESCRIPTIONS ROSE 65 PERCENT ALCOHOL ANTIBACTERIAL HAND SANITIZER- 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.

Active Ingredient

Alcohol: 65% (v/v)

Purpose

Antiseptic

Use

â–  To decrease bacteria on the skin that could cause disease
â– 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

Inactive ingredients

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Fragrance, Triehtanolamine, Red 33, Yellow 5

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BODY PRESCRIPTIONS ROSE 65 PERCENT ALCOHOL ANTIBACTERIAL HAND SANITIZER
ethyl alcohol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-278
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 65 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
WATER
GLYCERIN
CARBOMER 940
POLYOXYL 40 HYDROGENATED CASTOR OIL
D&C RED NO. 33
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50563-278-01 30 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 10/01/2020
Labeler — ENCHANTE ACCESSORIES INC. (186050696)
Establishment
Name Address ID/FEI Operations
Xiamen Afgamarine Biotechnology Co., Ltd. 420485152 manufacture (50563-278)

Revised: 10/2020 ENCHANTE ACCESSORIES INC.

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