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Pain Relieving by Cardinal Health

Medically reviewed on June 4, 2018

Dosage form: gel
Ingredients: MENTHOL 35mg in 1mL
Labeler: Cardinal Health
NDC Code: 37205-824

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.

Pain Relieving Gel

Active Ingredients

Active Ingredients                   
Menthol 3.5%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with • arthritis • backache • strains • sprains

Warnings:

For external use only

Ask a doctor before use if you have:

sensitive skin, are pregnant or breast feeding

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 after with cool water

Stop Use And Ask A Doctor If:

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

Keep out of reach of children:

If ingested, get medical help. Contact Poison Control Center immediately.

Directions:

• Adults / 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 cool dry place, lid closed tightly. keep away from excessive heat or open flame.

Inactive Ingredients:

Water, isopropyl alcohol, herbal extract (IIex paraguariensis), menthol, carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FDandC blue #1

Description

0  96295  11511  6  LOT  Distributed By: Cardinal Health, Dublin, OH 43017  www.myleader.com

NDC 37205-824-26  EXTRA STRENGTH Pain Relieving Gel  Provides Hours of Long Lasting Relief from:  Arthritis - Backache  Sore Muscles - Stiff Joints  Fast Acting  Greaseless  Vanishing Scent  SATISFACTION  GUARANTEED  4 FL OZ (118 mL)

Drug Facts  Distributed By: Cardinal Health, Dublin, OH 43017  www.myleader.com

Product Package Pain Relieving Gel

PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-824
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
TROLAMINE 
SILICON DIOXIDE 
METHYLPARABEN 
GLYCERIN 
PROPYLENE GLYCOL 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:37205-824-261 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/18/2012
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
Span Packaging Services LLC557434805manufacture(37205-824)

 
Cardinal Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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