HARMON Extra Strength Pain Relieving Gel

HARMON Extra Strength Pain Relieving Gel

Drug Labeling and Warnings

Drug Details

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HARMON EXTRA STRENGTH PAIN RELIEVING- menthol gel 
Harmon Stores Inc.

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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HARMON Extra Strength Pain Relieving Gel

Drug Facts


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:

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

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

ExtraStrengthPainRelieving118ml

HARMON EXTRA STRENGTH PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63940-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
TROLAMINE (UNII: 9O3K93S3TK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63940-100-04118 mL in 1 TUBE; Type 0: Not a Combination Product09/05/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/05/2012
Labeler - Harmon Stores Inc. (804085293)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services LLC557434805manufacture(63940-100)

Revised: 10/2019
 
Harmon Stores Inc.


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