PERFORM- menthol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Menthol USP 3.1%

Available from:

Performance Health LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Cooling Pain Relief Soothing temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort and arthritis. Condition worsens, symptoms persist more than 7 days, or clear up and reoccur

Authorization status:

OTC monograph not final

Summary of Product characteristics

PERFORM- MENTHOL GEL
PERFORMANCE HEALTH 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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PERFORM PAIN RELIEVING ROLL-ON
ACTIVE INGREDIENTS
Menthol USP 3.1%
PURPOS E
Cooling Pain Relief
US ES :
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
menthol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:59 316 -10 8
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Performance Health LLC
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
31 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
FD&C BLUE NO . 1 (UNII: H3R47K3TBD