HARMON EXTRA STRENGTH PAIN RELIEVING- menthol gel

HARMON Extra Strength Pain Relieving by

Drug Labeling and Warnings

HARMON Extra Strength Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Harmon Stores Inc., Span Packaging Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

HARMON EXTRA STRENGTH PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-100-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	09/05/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	09/05/2012

Labeler - Harmon Stores Inc. (804085293)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		117101131	manufacture(63940-100)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		557434805	manufacture(63940-100)