MUSCLE RUB- menthol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Anicare Pharmaceuticals Pvt. Ltd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Topical Analgesic Uses - Provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.

Authorization status:

OTC monograph not final

Summary of Product characteristics

MUSCLE RUB- MENTHOL GEL
ANICARE PHARMACEUTICALS PVT. 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._
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MUSCLE RUB GEL
_ACTIVE INGREDIENT_
Menthol 2.5%
_PURPOSE_
Topical Analgesic
_USES_
Provides soothing relief of minor arthritis pain, aching muscles,
joints and backaches.
_WARNINGS_
FOR EXTERNAL USE ONLY. USE ONLY AS DIRECTED. KEEP OUT OF REACH OF
CHILDREN TO AVOID ACCIDENTAL
POIS ONING.
Avoid contact with eyes or mucous membranes.
Discontinue use if excessive irritation of the skin develops.
Do not bandage tightly, apply to wounds, broken or irritated skin, or
use with a heating pad.
If condition worsens, or if symptoms persist for more than 10 days or
clear-up and occur again
within a few days, if skin redness or irritation develops, discontinue
use of this product and consult
a doctor.
For arthritis like conditions in children under 12, do not use.
Consult a doctor.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
Adults and children 12 years of age and older: apply to affected area
not more than 3 to 4 times daily
and gently massage until gel disappears.
Children under 12 years of age: do not use, consult a doctor
_OTHER INFORMATION_
Store at controlled room temperature 15°C to 30°C (59°F to 86°F)
Lot No. & Exp. Date: see crimp of tube.
_INACTIVE INGREDIENTS_
Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol,
PEG-40 Hydrogenated Castor
Oil, Sodium Hydroxide, Water
PRINCIPAL DISPLAY PANEL
MUSCLE RUB GEL
NET WT 1.25 OZ (35 g)
MUSCLE RUB
menthol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:470 46 -16 0
ROUTE OF ADMINISTRATION
TOPICAL
Anicare Pharmaceuticals Pvt. Ltd
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
0 .0 25 g in 1 g
INACTIVE INGREDIENTS
INGRED