KOFAL- 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:

Purpose External Analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

KOFAL- 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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KOFAL FUERTE OINTMENT 2 OZ (SKOTT)
_ACTIVE INGREDIENTS & PURPOSE_
PURPOSE
External Analgesic
_ACTIVE INGREDIENT_
_PURPOSE_
Methyl Salicylate 10.5%.............................
External Analgesic
_USES_
For the temporary relief of minor aches and pains of muscles and
joints associated with:
simple backache
arthritis
strains
sprains
_WARNINGS_
FOR EXTERNAL USE ONLY. Avoid contact with the eyes.
_DO NOT USE_
on broken or irritated skin
with a tight bandage
with a heating pad
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
excessive skin irritation occurs
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: consult a doctor
_OTHER INFORMATION_
store between 59° to 86°F (15° to 25°C)
do not use if clear seal over jar is broken, torn or missing
_INACTIVE INGREDIENTS_
camphor, menthol, methylparaben, paraffin, petrolatum, propylparaben.
_QUESTIONS OR COMMENTS?_
1-866-359-3478 M-F 9 AM - 5 PM EST or www.pharmadel.com
DISTRIBUTED BY/ DISTRIBUIDO POR:
Pharmadel LLC, Georgetown, DE 199747
PACKAGE LABEL & PRINCIPAL DISPLAY PANEL
KOFAL
methyl salicylate ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55758-109
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
Pharmadel LLC
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ 4LPZ )
METHYL SALICYLATE
10.5 g in 100 g
INACTIVE INGREDIENTS
INGRED