Pain Relief Cooling, Extra Strength: Package Insert and Label Information

PAIN RELIEF COOLING, EXTRA STRENGTH- menthol, unspecified form patch
J.R. Watkins, LLC.

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.

Drug Facts

Active Ingredient

Menthol 7.5%

Purpose

Topical Analgesic

Uses

Temporary relieves minor aches and pains of muscles and joints due to:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

For external use only.

Ask a doctor before use if you have

Sensitive Skin

When using this product

  • use only as directed
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly or use a heating pad

Stop use and ask a doctor if

  • excessive redness or irritation is present
  • condition worsens
  • pain persist for more than 7 days
  • symptoms clear up and occur again within a few days

Do not use

  • with any other creams, ointments, sprays, liniments, or other topical products containing menthol

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

Directions

Adults and children 12 years and over:

  • gently fold patch in half and remove one side of backing. Apply exposed adhesive to the site of pain.
  • remove remaining film from the other side and finish applying to skin
  • use on affected areas for up to 12 hours. Children 12 years of younger: ask a doctor

Other information

  • Store in a cool & dry place. Protect from excessive moisture. Do no refrigerate or freeze.

Inactive ingredients

Glyceryl Hydrogenated Rosinate, Mineral Oil, Styrene/Isoprene Copolymer

Questions or Comments?

J.R WATKINS, LLC
OAKLAND, CA 94612
1-888-384-1945

PRINCIPAL DISPLAY PANEL — 5 Patch Box

ESTD
1868
J.R.
WATKINS
REMEDIES FOR BODY™

COOLING

PAIN RELIEF PATCHES

WITH 7.5% NATURAL MENTHOL

EXTRA-STRENGTH*

Crafted to provide
lasting pain relief

Cooling therapy to
aid recovery

Mess-free application

BACKACHES, SORE MUSCLES & JOINT PAIN
FAST ACTING COOLING RELIEF

5 INDIVIDUALLY PACKAGED PATCHES

USED BY
ATHLETES

5.51″x3.94″ (14 cm x 10 cm)

PRINCIPAL DISPLAY PANEL -- 5 Patch Box
(click image for full-size original)
PAIN RELIEF COOLING, EXTRA STRENGTH
menthol, unspecified form patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72342-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 105 mg
Inactive Ingredients
Ingredient Name Strength
Glyceryl Rosinate
Mineral Oil
Styrene/Isoprene/Styrene Block Copolymer
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72342-100-05 5 POUCH in 1 BOX contains a POUCH
1 1 PATCH in 1 POUCH This package is contained within the BOX (72342-100-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 11/01/2022
Labeler — J.R. Watkins, LLC. (081071049)

Revised: 10/2022 J.R. Watkins, LLC.

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