OTC Medication Information: DHT X TONIC

DHT X TONIC- oatmeal solution
IDOOGEN CO., LTD.

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

ACTIVE INGREDIENTS : Colloidal Oatmeal 0.007%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS :
Butylene Glycol, Polyoxyethylene Hydrogenated Castor Oil, Menthol, Salicylic Acid, Panthenol, Aloe Ferox Leaf Extract, Artemisia Vulgaris Extract, Camellia Sinensis Leaf Extract, Chrysanthemum Sibiricum Extract, Cnidium Officinale Root Extract, Coix Lacryma-Jobi Ma-yuen Seed Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sophora Flavescens Root Extract, Ethanol, Perfume(5PO2779), Triethanolamine, Water

PURPOSE

PURPOSE : Skin Protectant

WARNINGS

WARNINGS :
1. It is not used in th following cases. Skin and scalp there is a skin wound or mucous membrane, such as eczema, damaged
2. People such as the following, consult your doctor and pharmacist before using this product. People who have (such as dermatitis rash, redness, itching, etc.) allergy symptoms caused by cosmetics and medicine came out
3. Be discontinued immediately the use of this product in the following cases, consult your doctor or pharmacist, at the time of consultation, as far as possible : If rash, erythema, itching, swelling, and the like are displayed
4. Avoid contact with eyes. * If product gets into the eyes rinse well with water immediately. * it is recommended that you consult with an ophthalmologist if symptoms are severe
– For external use only
5. Keep out of reach of babies and children
– Do not store near high heat or flame
– Do not keep it in the place where the temperature is extremely hot or low and exposed the direct sunlight.
– Do not put in other containers for prevent abuse and keep quality

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children

INDICATIONS & USAGE

INDICATION AND USAGE :
Shake the DHT-X Tonic, and spray onto the parts showing hair loss and massage with fingertips until the product is absorbed into the scalp and hair

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION :
Take an adequate amount of this product and use the tonic 3 times a week

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DHT X TONIC
oatmeal solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69281-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (OATMEAL) OATMEAL 0.003 mg in 55 mL
Inactive Ingredients
Ingredient Name Strength
Butylene Glycol
Menthol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69281-010-01 55 mL in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 10/01/2014
Labeler — IDOOGEN CO., LTD. (688271800)
Registrant — IDOOGEN CO., LTD. (688271800)
Establishment
Name Address ID/FEI Operations
IDOOGEN CO., LTD. 688271800 manufacture (69281-010)

Revised: 10/2014 IDOOGEN CO., LTD.

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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