KOFAL ORIGINAL- methyl salicylate ointment

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

PHARMADEL LLC

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

OTC DRUG

Θεραπευτικές ενδείξεις:

For the temporary relief of minor aches and pains of muscles and joints associated with - backaches - arthritis - strains - bruises - sprains

Καθεστώς αδειοδότησης:

OTC monograph not final

Αρχείο Π.Χ.Π.

KOFAL ORIGINAL- METHYL SALICYLATE OINTMENT
PHARMADEL LLC
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KOFAL ORIGINAL AZUL (KENIL)
_DRUG FACTS_
_DRUG FACTS_
_ACTIVE INGREDIENT AND PURPOSE_
_ACTIVE INGREDIENT_
_PURPOSE_
Mythyl Salicylate 12%........................................
Topical Analgesic
_USE_
For the temporary relief of minor aches and pains of muscles and
joints associated with
backaches
arthritis
strains
bruises
sprains
WARNINGS
FOR EXTERNAL USE ONLY. AVOID CONTACT WITH THE EYES
DO NOT
apply to wounds or damaged skin
bandage tightly
STOP USE AND ASK A DOCTOR IF
condition worsens, or if 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
immediately.
DIRECTIONS
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: apply to affected area
not more
than 3 to 4 times daily
CHILDREN UNDER 2 YEARS OF AGE: consult a doctor
_OTHER INFORMATION_
store in a cool dry place between (59-86°F)15-30°C
don’t use if clear seal over jar is broken, torn, or missing
INACTIVE INGREDIENTS
camphor, cetyl alcohol, eucalyptus oil, glyceryl monostearate,
menthol, methylparaben,
paraffin, polysorbate 20, propylparaben,
stearic acid, trolamine, water
PRINCIPAL DISPLAY PANEL
KOFAL ® Original
Penetrating pain relieving ointment
Pomada analgesica con accion penetrante
4 oz (113 g)
KOFAL ORIGINAL
methyl salicylate ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55758-108
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
12 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
EU