HARMON Extra Strength Pain Relieving

Dosage form: gel
Ingredients: MENTHOL 3.5mL in 100mL
Labeler: Harmon Stores Inc.
NDC Code: 63940-100

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.

HARMON Extra Strength Pain Relieving Gel

HARMON Extra Strength Pain Relieving Gel


Active Ingredient

                     
Menthol 3.5%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with

• arthritis  • 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 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:

Conditions 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), carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FD andC blue #1

Dist. by Harmon Stores, Inc.

Union, NJ 07083 USA

Harmon Stores, Inc.

Visit us at: www.facevalues.com

12015 REV 1

Harmon Satisfaction

Guaranteed or

Your Money Back

Harmon

Face Values

Extra Strength

Pain Relieving

cooling menthol therapy

Penetrating - Long Lasting

Helps Relieve: Arthritis, Back Pain, Sore Muscles and Joints

HARMON Extra Strength Pain Relieving Gel 118ml

HARMON EXTRA STRENGTH PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
ILEX PARAGUARIENSIS LEAF 
TROLAMINE 
SILICON DIOXIDE 
METHYLPARABEN 
GLYCERIN 
PROPYLENE GLYCOL 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:63940-100-04118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34809/05/2012
Labeler - Harmon Stores Inc. (804085293)
Establishment
NameAddressID/FEIOperations
Span Packaging Services LLC557434805manufacture(63940-100)

Revised: 09/2012
 
Harmon Stores Inc.

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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