BODY PRESCRIPTIONS INSTANT HAND SANITIZER VITAMIN E: Package Insert and Label Information

BODY PRESCRIPTIONS INSTANT HAND SANITIZER VITAMIN E- alcohol gel
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.

Alcohol Denat. 75%

Purpose

Antiseptic

Use

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

Stop use and ask a doctor if skin irritation develops

keep out of reach of children

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 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, Glycerin, PEG-40 Hydrogenated castor oil, Carbomer, Fragrance, Triethanolamine, Tocopheryl Acetate

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BODY PRESCRIPTIONS INSTANT HAND SANITIZER VITAMIN E
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-198
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
CARBOMER 934
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50563-198-01 236 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 06/01/2020
Labeler — ENCHANTE ACCESSORIES INC. (186050696)
Establishment
Name Address ID/FEI Operations
Xiamen Chengda Industrial Co.,Ltd 540042034 manufacture (50563-198)

Revised: 06/2020 ENCHANTE ACCESSORIES INC.

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