Pain Relieving Warming Balm: Package Insert and Label Information

PAIN RELIEVING WARMING BALM- methyl salicylate and menthol, unspecified form gel
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 Ingredients	Purpose
MENTHOL 1.25%	EXTERNAL ANALGESIC
METHYL SALICYLATE 10.0%	EXTERNAL ANALGESIC

Uses

temporarily relieves minor aches and pains of muscles and joints associated with

• simple backache
• strains
• bruises
• sprains
• arthritis

Warnings

For external use only.

Allergy alert

If prone to allergic reaction form aspiring or salicylates, consult a doctor before use.

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
• taking anticoagulant medications

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

• Use only as directed
• Adults and children 3 years and older: Apply to affected area not more than 3-4 times daily.
• Children under 3 years of age: Ask a doctor.

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

Capsicum oleoresin, glyceryl stearate SE, phenoxyethanol, stearic acid, stearyl alcohol, tropolone, water

Questions or Comments?

1-800-243-9423

PRINCIPAL DISPLAY PANEL — 93 g Tube Label

99% NATURAL

ESTD J.R. 1868
WATKINS
REMEDIES FOR BODY™

PAIN RELIEVING
WARMING
BALM

NATURAL
MENTHOL

METHYL
SALICYLATE

FAST–ACTING
LONG–LASTING
PAIN RELIEF

NET WT. 3.3 OZ (93 g)

PAIN RELIEVING WARMING BALM methyl salicylate and menthol, unspecified form gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72342-030 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Methyl Salicylate (SALICYLIC ACID) Methyl Salicylate 10 g in 100 g Menthol, Unspecified Form (Menthol, Unspecified Form) Menthol, Unspecified Form 1.25 g in 100 g

Inactive Ingredients Ingredient Name Strength Water Glyceryl Stearate SE Stearic Acid Phenoxyethanol Tropolone CAPSICUM OLEORESIN Stearyl Alcohol

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72342-030-93 93 g in 1 TUBE None

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)

Revised: 12/2022 J.R. Watkins, LLC.