MYORX LOW DOSE PAIN RELIEVING- menthol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

PureTek Corporation

INN (International Name):

MENTHOL

Composition:

MENTHOL 5 uL in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

Authorization status:

OTC monograph not final

Summary of Product characteristics

MYORX LOW DOSE PAIN RELIEVING - MENTHOL CREAM
PURETEK CORPORATION
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Menthol 0.5%
PURPOS E
Topical Analgesic
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
US ES
For the temporary relief of minor aches and pains of muscles and
joints associated with simple
backache, arthritis, strains, bruises, sprains.
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT
apply on wounds or damaged skin
bandage tightly
WHEN USING THIS PRODUCT
avoid contact with the eyes
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few days
DIRECTIONS
Adults and children 2 years of age and older: apply to affected area
not more than 3 to 4 times daily.
Children under 2 years of age: consult a doctor.
INACTIVE INGREDIENTS
Aloe Barbadensis (Aloe Vera) Leaf Juice, Borago Officinalis Seed Oil,
Capsaicin, Carbomer,
Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Eucalyptus
Globulus Leaf Oil, Fructose,
Menhaden Oil, Methyl Salicylate, Methylparaben, Phenoxyethanol,
Propylene Glycol, Propylparaben,
Purified Water, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium
EDTA, Tocopheryl Acetate
(Vitamin E), Triethanolamine, Vitis Vinifera (Grape) Seed Oil.
Store at controlled room temperature 59°-86°F (15°-30°C).
LABEL
MYORX LOW DOSE PAIN RELIEVING
menthol cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:59 0 8 8 -9 54
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
5 uL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
BO RAGE O IL (UNII: F8 XAG1755S)
CAPSAICIN (UNII: S0 7O44R1ZM)