OTC Medication Information: BODY PRESCRIPTIONS INFUSED WITH VITAMIN E Sugar Cookie ANTIBACTERIAL HAND

BODY PRESCRIPTIONS INFUSED WITH VITAMIN E SUGAR COOKIE ANTIBACTERIAL HAND- benzalkonium chloride lotion
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

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

■ To help reduce the bacteria on the skin

WARNINGS

For external use only

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.

Directions

Apply a small amount to palm and rub hands together thoroughly

Other Information

Do not store above 105F

May doscolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, Cetearyl Alcohol, Mineral Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate, C13-14 Isoparaffin, Polyacrylamide, Laureth-7, Phenoxyethanol, Benzyl Alcohol, Benzoic Acid, Fragrance (Parfum), Citric Acid, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Red 4, Yellow 5, Blue 1

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BODY PRESCRIPTIONS INFUSED WITH VITAMIN E SUGAR COOKIE ANTIBACTERIAL HAND
benzalkonium chloride lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-466
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
GLYCERYL STEARATE SE
PEG-100 STEARATE
C13-14 ISOPARAFFIN
GLYCERIN
WATER
POLYACRYLAMIDE (1500 MW)
LAURETH-7
PHENOXYETHANOL
BENZYL ALCOHOL
BENZOIC ACID
CITRIC ACID MONOHYDRATE
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES
.ALPHA.-TOCOPHEROL ACETATE
FD&C RED NO. 4
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
CETOSTEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50563-466-01 236.6 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 07/04/2021
Labeler — ENCHANTE ACCESSORIES INC. (186050696)
Establishment
Name Address ID/FEI Operations
Xiamen Afgamarine Biotechnology Co., Ltd. 420485152 manufacture (50563-466)

Revised: 07/2021 ENCHANTE ACCESSORIES INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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