UBREDOL- methyl salicylate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Pharmadel LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

UBREDOL- METHYL SALICYLATE OINTMENT
PHARMADEL 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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UBREDOL METHYL SALICYLATE 10% (WP)
_DRUG FACTS_
_ACTIVE INGREDIENT & PURPOSE_
_ACTIVE INGREDIENT_
_PURPOSE_
Methyl salicylate 10% ..................
Topical analgesic
_USES_
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. AVOID CONTACT WITH THE EYES.
_DO NOT_
apply on wounds or irritated skin
bandage tightly
STOP USE AND ASK DOCTOR IMMEDIATELY IF
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 care professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed get medical help, or contact a Poison Control Center
immediately.
_DIRECTIONS_
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: apply to affected area
not more
than 3 to 4 times daily
CHILDREN UNDER 12 YEARS OF AGE: do not use, consult a doctor
_OTHER INFORMATION_
store between 59°- 86°F (15 - 30°C)
do not use if clear seal over jar is broken, torn or missing
_INACTIVE INGREDIENTS_
camphor, D&C yellow #11, eucalyptus oil, lanolin oil, levomenthol,
mineral oil, petrolatum,
propylparaben, tea tree oil
DISTRIBUTED BY:
PHARMADEL LLC
New Castle, DE 19720
[phone]
_PRINCIPAL DISPLAY PANEL_
Pharmadel LLC
UBREDOL
methyl salicylate ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55758-377
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
10 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CAMPHOR, (-)- (UNII: 213N3S8275)
LEVOMENTHOL (UNII: BZ1R15MTK7)
D&C YELLOW NO. 11 (UNII: 44F3HYL9