PAIN RELIEVING COOLING- menthol, unspecified form gel

Pain Relieving Cooling by

Drug Labeling and Warnings

Pain Relieving Cooling by is a Otc medication manufactured, distributed, or labeled by J.R. Watkins, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

MENTHOL 3%

Purpose

EXTERNAL ANALGESIC

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• sprains

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Do not use

• on wounds or damaged skin
• with a heading pad

When using this product

• avoid contact with eyes, nostrils and mouth
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• rash or irritation occurs

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

Directions

• Use only as directed
• Adults and children 2 years and older: Apply liberally to painful area not more than 3-4 times daily.
• Children under 2 years of age: Ask a doctor.
• Wash hands carefully after using

Other information

• do not use if tamper evident seal is not intact
• store away from children
• store in dry, well-ventilated conditions at room temperature (59-77°F)

Inactive ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 60, SD alcohol 40B, tromethamine, water

Questions or Comments?

1-800-243-9423

PRINCIPAL DISPLAY PANEL - 93 g Tube Label

97% NATURAL

ESTD
1868

J.R.
WATKINS
REMEDIES FOR BODY™

PAIN RELIEVING
COOLING
GEL

NATURAL
MENTHOL

TEMPORARY
RELIEF FOR
MUSCLES & JOINTS

NET WT. 3.3 OZ (93 g)

INGREDIENTS AND APPEARANCE

PAIN RELIEVING COOLING 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72342-020
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	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Water (UNII: 059QF0KO0R)
Tromethamine (UNII: 023C2WHX2V)
Polysorbate 60 (UNII: CAL22UVI4M)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72342-020-93	93 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2019

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

Labeler - J.R. Watkins, LLC. (081071049)