BALSAMO DE UBRE MASCURA methyl salicylate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)

Available from:

Pharmalab Enterprises Inc.

INN (International Name):

METHYL SALICYLATE

Composition:

METHYL SALICYLATE 10.5 g in 90 g

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

BALSAMO DE UBRE MASCURA- METHYL SALICYLATE OINTMENT
PHARMALAB ENTERPRISES INC.
_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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DRUG FACTS
ACTIVE INGREDIENT PURPOSE
Methyl Salicylate 10.5 %
............................................Topical Analgesic
US ES
For the temporary relief of minor aches and pains of muscles and
joints associated with simple
backache, arthritis, strains and sprains
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE OTHERWISE THAN AS DIRECTED
DO NOT USE
with a heating pad
with a tight bandage
on eyes, mucous membranes, broken or irritated skin
over extensive areas of the body
on a child under 12 years of age
STOP USE AND ASK A DOCTOR IMMEDIATELY IF
pain persists for more than 7 days, or redness is present, or in
conditions affecting children under 12
years of age
excessive irritation of skin develops
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL POISONING.
If swallowed, induce vomiting and call a physician or contact a Poison
Control Center right away.
DIRECTIONS
Adults and Children 12 years and older: apply generously and gently
massage into painful area until
the product disappears. Repeat 3 to 4 times daily
Children under 12 years of age: ask a doctor
OTHER INFORMATION
Store at 15 C to 25 C (59 F to 77 F)
Enter section text here
QUESTIONS? call 1-800-560-5223
Pharmalab Enterprises Inc.
BALSAMO DE UBRE MASCURA
methyl salicylate ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:1450 5-26 3
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
METHYL SALICYLATE (UNII: LAV5U50 22Y) (METHYL SALICYLATE -
UNII:LAV5U50 22Y)
METHYL SALICYLATE 10 .5 g in 9 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41)
D&C YELLO W NO . 10 (UNII: 35SW5