DENOREX THERAPEUTIC- coal tar and menthol shampoo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Ultimark Products LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis Controls scalp itch - relieves and helps stop the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis - extra relief of itching due to dandruff

Authorization status:

OTC monograph final

Summary of Product characteristics

DENOREX THERAPEUTIC- COAL TAR AND MENTHOL SHAMPOO
ULTIMARK PRODUCTS LLC
_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._
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DENOREX THERAPEUTIC
DRUG FACTS
_ACTIVE INGREDIENTS:_
Coal tar solution 9.0% v/v (equivalent to 1.8% coal tar)
_PURPOSE:_
Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis
_ACTIVE INGREDIENTS:_
Menthol 1.5%
_PURPOSE:_
Controls scalp itch
_USES:_
relieves and helps stop the recurrence of scalp itching, irritation,
redness, flaking and
scaling associated with dandruff, seborrheic dermatitis and psoriasis
extra relief of itching due to dandruff
_WARNINGS:_
FOR EXTERNAL USE ONLY
DO NOT USE:
for prolonged periods without consulting a doctor
this product with other forms of psoriasis therapy such as ultraviolet
radiation or
prescription drugs unless directed to do so by a doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
condition covers a large area of the body.
WHEN USING THIS PRODUCT:
avoid contact with the eyes. If contact occurs, rinse thoroughly with
water.
use caution in exposing skin to sunlight after applying. It may
increase your tendency
to sunburn for up to 24 hours after application.
STOP USE AND ASK A DOCTOR IF:
condition worsens or does not improve after regular use of this
product as directed.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS:_
shake well
apply to wet hair
gently massage into hair and scalp to work up a lather
rinse thoroughly and repeat
for best results, use at least twice a week or as directed by a doctor
_INACTIVE INGREDIENTS_
alcohol 7.3%, avocado oil, chloroxylenol, citric acid, dimethicone
copolyol, FD&C red
#40, fragrance, glycol distearate, hydroxypropyl methylcellulose,
lauramide DEA,
panthenol (provitamin B5), PEG-30 lanolin, quaternium-80,
ricinoleamidopropyl ethyldimonium ethosulfate, TEA lauryl sulfate,