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

Pain Relieving Warming Balm by

Drug Labeling and Warnings

Pain Relieving Warming Balm 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

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl Salicylate	10 g  in 100 g
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Stearic Acid (UNII: 4ELV7Z65AP)
Phenoxyethanol (UNII: HIE492ZZ3T)
Tropolone (UNII: 7L6DL16P1T)
CAPSICUM OLEORESIN (UNII: UW86K581WY)
Stearyl Alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72342-030-93	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)