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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63940-150
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63940-150-03	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/05/2012	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	09/05/2012	12/31/2021

Labeler - Harmon Stores Inc. (804085293)

Name	Address	ID/FEI	Business Operations
Establishment
Span Packaging Services LLC		117101131	manufacture(63940-150)

Name	Address	ID/FEI	Business Operations
Establishment
Span Packaging Services LLC		557434805	manufacture(63940-150)

Revised: 3/2021

Document Id: bd2d8e91-cea3-75c2-e053-2995a90a41c7

Set id: 389c0cf0-96cd-43ad-a41c-f6f638d522d5

Version: 6

Effective Time: 20210310

Harmon Stores Inc.