HARMON Extra Strength Pain Relieving Roll-On

HARMON Extra Strength Pain Relieving Roll-On

Drug Labeling and Warnings

Drug Details

k">

HARMON EXTRA STRENGTH PAIN RELIEVING ROLL-ON- 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.

----------

HARMON Extra Strength Pain Relieving Roll-On

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:

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

Keep out of reach of children:

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 Extra Strength Pain Relieving Roll-On

ExtraStrengthPainRelievingRollOn89ml

HARMON EXTRA STRENGTH PAIN RELIEVING ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63940-150
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: 63940-150-0389 mL in 1 BOTTLE, WITH APPLICATOR; 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(63940-150)

Revised: 10/2019
 
Harmon Stores Inc.


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.