PAINZAWAY PAIN RELIEVING GEL- menthol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Indiana Botanic Gardens

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

topical analgesic ■ Temporary relief of minor aches and pains of muscles & joints associated with simple backache, arthritis, bruises and sprains. ■ Provides cooling pain relief. condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAINZAWAY PAIN RELIEVING GEL- MENTHOL GEL
INDIANA BOTANIC GARDENS
_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._
----------
PAINZAWAY PAIN RELIEVING GEL
ACTIVE INGREDIENT
Menthol 4.6%
PURPOSE
topical analgesic
USES
■ Temporary relief of minor aches and pains of muscles & joints
associated with simple
backache, arthritis, bruises and sprains. ■ Provides cooling pain
relief.
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
■ Do not heat ■ Do not microwave ■ Do not use near open flame
■ Do not add to hot
water or any container when heating water. May cause splattering and
result in burns. ■
Avoid contact with eyes ■ Do not apply to wounds or damaged skin ■
Do not 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
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
■ SEE THE IMPORTANT WARNINGS UNDER "WHEN USING THIS PRODUCT"
■ 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 physician.
OTHER INFORMATION:
Use only if seal is unbroken.
INACTIVE INGREDIENTS
Aloe Vera Concentrate, Carbomer 940, Emu Oil, FD&C Blue #1,
Glucosamine Sulfate,
Glycerin, Green Tea Fragrance, Imidazolidinyl Urea, MSM Powder,
Propylene Glycol, SD
Alcohol 39B, Triethanolamine, Water
QUESTIONS?
1-800-644-8327
MANUFACTURED BY
INDIANA BOTANIC GARDENS, INC.
3401 W. 37TH AVE., HOBART, IN 46342
Website: BotanicChoice.com
PainzAway®
PAIN RELIEVING GEL
NET WT. 5 OZ.
PAINZAWAY PAIN RELIEVING GEL
menthol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:10578-135
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MENTHOL (UN