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Perform

Performance Health LLC

Perform Pain Relieving Roll-On


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Menthol USP 3.1%

Purpose

Cooling Pain Relief

Uses:

Soothing temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort and arthritis.

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Ask a Doctor Before Using if You:

Have sensitive skin, are pregnant or are breastfeeding

When Using This Product:

  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds, damaged or irritated skin,  or if excessive irritation develops
  • Do not bandage or use with heating pad or device, ointments, creams, sprays, liniments
  • Wash hands with cool water after using

Stop Use and Ask a Doctor If:

Condition worsens, symptoms persist more than 7 days, or clear up and reoccur

Keep Out of Reach of Children:

If ingested, get medical help Contact Poison Control Center immediately

Directions:

  • Adults and Children 2 years and older: Roll on the affected area up to 4 times daily
  • Children under 2 years of age: Consult a physician


Other Information:

Store in a cool, dry place, with lid closed tightly.

Inactive Ingredients:

Carbomer, FD and C Blue 1, Glycerine USP, Ilex Paraguariensis Extract, Isopropyl Alcohol USP, Propylene Glycol USP, Methyl Paraben, Purified Water, Silicon Dioxide, Triethanolamine

Questions or Comments?

1-800-755-2584

Representative Labeling

Perform

Perform

MENTHOL GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59316-108
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 31 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
GLYCERIN
ILEX PARAGUARIENSIS LEAF
ISOPROPYL ALCOHOL
propylene glycol
METHYLPARABEN
water
SILICON DIOXIDE
TROLAMINE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59316-108-15 89 in 1 BOTTLE, WITH APPLICATOR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2009-12-30


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Be sure to consult your doctor before taking any medication!
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