OTC Medication Information: BODY PRESCRIPTIONS Sweet Pine INFUSED WITH VITAMIN E ANTIBACTERIAL FOAMING HAND

BODY PRESCRIPTIONS SWEET PINE INFUSED WITH VITAMIN E ANTIBACTERIAL FOAMING HAND- benzalkonium chloride soap
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

■ For hand washing to decrease 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 hands, lather for 20 seconds, then rinse with warm water.

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Tocopheryl Acetate, Blue 1, Yellow 5

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BODY PRESCRIPTIONS SWEET PINE INFUSED WITH VITAMIN E ANTIBACTERIAL FOAMING HAND
benzalkonium chloride soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-459
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
COCAMIDOPROPYL BETAINE
DMDM HYDANTOIN
DISODIUM HEDTA
CITRIC ACID MONOHYDRATE
.ALPHA.-TOCOPHEROL ACETATE
WATER
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50563-459-01 254 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 07/02/2021
Labeler — ENCHANTE ACCESSORIES INC. (186050696)
Establishment
Name Address ID/FEI Operations
Xiamen Afgamarine Biotechnology Co., Ltd. 420485152 manufacture (50563-459)

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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