ULTRA STRENGTH MUSCLE RUB- camphor, menthol, methyl salicylate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Camphor 4%, Menthol 10%, Methyl salicylate 30%

Available from:

The Mentholatum Company

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Camphor - Topical analgesic Menthol - Topical analgesic Methyl salicylate - Topical analgesic temporarily relieves 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

ULTRA STRENGTH MUSCLE RUB- CAMPHOR, MENTHOL, METHYL SALICYLATE CREAM
THE MENTHOLATUM COMPANY
_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 INGREDIENTS
Camphor 4%
Menthol 10%
Methyl salicylate 30%
PURPOSE
Camphor - Topical analgesic
Menthol - Topical analgesic
Methyl salicylate - Topical analgesic
USES
temporarily relieves minor aches and pains of muscles and joints
associated with:
simple backache
arthritis
strains
bruises
sprains
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
use only as directed
do not get into eyes or on mucous membranes
do not apply to wounds or damaged skin
do not bandage tightly
do not use with a heating pad or apply external heat
STOP USE AND ASK A DOCTOR IF
skin redness or excessive irritation of the skin occurs
condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few
days
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
adults and children 12 years and over: apply to affected area not more
than 3 to 4
times daily
children under 12 years: ask a doctor
INACTIVE INGREDIENTS
aloe barbadensis leaf extract, carbomer 940, cocos nucifera (coconut)
oil, edetate
disodium, glyceryl stearate, isopropyl myristate, lanolin, mineral
oil, polysorbate 60,
purified water, sodium lauryl sulfate, stearic acid, trolamine,
vitamin E
QUESTIONS?
Call 1-877-636-2677 MON - FRI 9 AM to 5 PM (EST)
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
ULTRA STRENGTH MUSCLE RUB
camphor, menthol, methyl salicylate cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:10742-6000
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHE