PERFORM- menthol gel

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Disponible des:

Performance Health LLC

Vía de administración:

TOPICAL

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

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

Estat d'Autorització:

OTC monograph not final

Fitxa tècnica

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 GEL
DRUG FACTS
ACTIVE INGREDIENT
Menthol USP 3.1%
_PURPOSE_
Cooling Pain Relief
US ES :
Soothing temporary relief from minor aches and pains associated with
sore muscles strains joint
discomfort arthritis and tendonitis
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 a
heating pad or device, ointments,
creams, sprays, liniments - Wash hands with cool water after using
STOP USE AND ASK A DOCTOR IF:
KEEP OUT OF REACH OF CHILDREN:
If ingested, get medical help. Contact Poison Control Center
immediately.
DIRECTIONS :
Adults and Children 2 years and older: Massage onto affected area up
to 4 times daily
Children under 2 years of age: Consult physician
OTHER INFORMATION:
Store in a cool, dry place
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
Performance Health LLC
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:59 316 -10 6
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
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
CARBO MER HO MO PO LYMER TYPE C (UNII: 4Q9 3RCW27E)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6 A3C0 OX