PAINPATROL PROFESSIONAL PAIN RELIEF- menthol, unspecified form gel

PainPatrol Professional Pain Relief by

Drug Labeling and Warnings

PainPatrol Professional Pain Relief by is a Otc medication manufactured, distributed, or labeled by SmartScience Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Natural Menthol, USP (8.5%)

Purpose

Topical Analgesic

Uses

Temporarily relieves foot, ankle and leg pain associated with:

• arthritis
• muscle aches
• muscle strains
• muscle sprains
• joint pain

Warnings

For external use only: Flammable: Keep away from excessive heat or open flame.

• Ask a doctor before use is you have sensitive skin or if you are taking any blood thinners,

When using this product

Do not use on wounds or irritated skin

• Do not bandage tightly or usewith a heating pad
• Wash hands after use with cool water

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

• Keep out of reach of children. If accidentally swallowed,contact a doctor or poison control center immediately

• Stop use and ask a doctor if condition worsens or if pain persists for more than 7 days, or clears up, then reoccurs within a few days.

Directions

Use only as directed

• Do not use on children under 12 years of age.
• Roll onto affected area no more than four times daily. Shake well before each use.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Extract, Boswellia Serrata Extract, Camphor, Carbomer, Chondroitin Sulfate, Glucosamine Sulfate, Glycerin, Ilex Paraguarensis Extract, Isopropyl Alcohol, Methyl Paraben, Methylsulfonylmethane, Peppermint Oil, Polysorbate 20, Propylene Glycol, Triethanolamine, Purified Water

Other Information

Questions or comments?

Call (877) 383-2334.

Store in a cool dry place with the cap tightly closed. Note: Because this product contains natural ingredients, color may vary.

SPL UNCLASSIFIED SECTION

Manufactured by:
SmartScience Laboratories, Inc
13760 Reptron Blvd., Tampa, FL 33626

PRINCIPAL DISPLAY PANEL - 88 ML Bottle Label

Clinical Strength Menthol Formula

PainPatrol™
Professional Pain Relief

Pain Relief for arthritis, joints and muscles.
Also contains Glucosamine Chondroitin Arnica Boswellia

No Mess Applicator.
3FL OZ (88ML)

INGREDIENTS AND APPEARANCE

PAINPATROL PROFESSIONAL PAIN RELIEF 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64479-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	85 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64479-200-10	88 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	03/10/2019
2	NDC: 64479-200-12	944 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	03/10/2019

Labeler - SmartScience Laboratories, Inc. (035907919)