OTC Medication Information: April Bath and Shower Sweet Blossom Scented Hand Sanitizer Anti-Bacterial

APRIL BATH AND SHOWER SWEET BLOSSOM SCENTED HAND SANITIZER ANTI-BACTERIAL — chloroxylenol liquid
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

Chloroxylenol 0.5%

Purpose

Antiseptic

Uses

To decrease bacteria on the skin that could cause diseases

Recommended for repeated use

For external use only

Flammable

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 and ask a doctor if skin irritation develops

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away

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 Ingredient:

Benzethonium Chloride, Alcohol, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate, may contain D and C Red No. 33, D and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

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label
(click image for full-size original)

APRIL BATH AND SHOWER SWEET BLOSSOM SCENTED HAND SANITIZER ANTI-BACTERIAL
chloroxylenol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-114
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 0.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER COPOLYMER TYPE A
TROLAMINE
EDETATE DISODIUM
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
ALCOHOL
FD&C YELLOW NO. 6
FD&C RED NO. 40
POLYOXYL 40 HYDROGENATED CASTOR OIL
BENZETHONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50563-114-01 236 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 06/18/2012
Labeler — ENCHANTE ACCESSORIES INC. (186050696)
Registrant — Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
Establishment
Name Address ID/FEI Operations
Zhejiang Aidi Cosmetics Co., Ltd. 530876820 manufacture

Revised: 06/2012 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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