Kemagel® Pain Relief - Menthol Gel

Drug Labeling and Warnings

Drug Details [pdf]

KEMAGEL PAIN RELIEF- menthol gel 
Pharmaplast SAE

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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Kemagel® Pain Relief - Menthol Gel

Active ingredient

Menthol 10%

Purpose

Topical analgesic

Uses: temporarily relieves minor pain associated with: arthritis, simple backache, muscle strains, sprains, bruises & cramps 

Warnings: For external use only

When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes and mucous membranes, do not apply to wounds or damaged, broken or irritated skin, a transient burning sensation or redness may occur upon application but generally disappears in several days, if severe burning sensation occurs, discontinue use immediately & do not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions: adults and children over 12 years: apply to affected area squeeze desired amount of Kemagel ® Pain Relief gel onto affected area, massage dispensed gel into painful area until thoroughly absorbed, repeat as necessary, but no more than 3 to 4 times daily, IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER, children 12 years or younger: ask a doctor

Inactive ingredients Water, Carbomer, Sodium Hyaluronate, Sodium hydroxide, Camphor, Glycerin, Eucalyptol, Propylene glycol, Methylene blue.

Fast Acting Therapy

Packaging

KEMAGEL PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28691-1010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
GLYCERIN (UNII: PDC6A3C0OX)
EUCALYPTOL (UNII: RV6J6604TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLENE BLUE (UNII: T42P99266K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 28691-1010-1	1 in 1 CARTON	09/01/2016	07/24/2019
1		75 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2016	07/24/2019

Labeler - Pharmaplast SAE (557735337)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaplast SAE		557735337	manufacture(28691-1010)

Revised: 7/2019

Document Id: 0c8b335e-4915-4118-8ee9-d738b52993fa

34390-5

Set id: 05c3ce49-47cc-4237-b6ca-1f062b9a02a0

Version: 3

Effective Time: 20190724