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Topical

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Unit Dose Services

Topical Pain Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient











Purpose




Keep out of reach of children

Uses

Discontinue use and consult a physician if condition worsens or irritation develops. Pain persists for more than 7 days. If pain clears up and then redevelops.

Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor.



Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.


Inactive Ingredients: Carbomer, Cetearyl Alcohol, Cypress Oil, Glyceryl Stearate, Green 3 (CI# 42053), Hypromellose, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol, Polysorbate-60, Propylene Glycol, sodium Hydroxide, Stearyl Alcohol, Water.


Topical

TOPICAL PAIN RELIEF (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM

Topical

Topical

Methyl Salicylate, Menthol, capsaicin CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50436-9990(NDC:76074-120)
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
methyl salicylate METHYL SALICYLATE 20 g
MENTHOL 5 g
capsaicin CAPSAICIN .0355 g

Inactive Ingredients

Ingredient Name Strength
CARBOMER 934
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
FD&C GREEN NO. 3
HYPROMELLOSE 2208 (100000 MPA.S)
ISOPROPYL PALMITATE
METHYLISOTHIAZOLINONE
PHENOXYETHANOL
POLYSORBATE 60
propylene glycol
SODIUM HYDROXIDE
stearyl alcohol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50436-9990-1 120 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2011-01-15


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Be sure to consult your doctor before taking any medication!
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