MUSCLE BALM (menthol, unspecified form, camphor- synthetic ointment

Muscle Balm by

Drug Labeling and Warnings

Muscle Balm by is a Otc medication manufactured, distributed, or labeled by Natural Essentials, Inc., NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Camphor 11 %

Menthol 11%

Purpose

Topical Analgesic

Topical Analgesic

Uses

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

• Over-Exertion
• Simple backache
• Arthritis
• Strains
• Sprains

Warnings

For external use only.

When using this product

• avoid contact with eyes or mucous membranes
• do not apply to open wounds or damaged skin
• do not bandage or use a heating pad

Stop use and ask a doctor if

• condition worsens
• severe skin irritation occurs
• pain persists for more than 7 days
• pain clears up then recurs a few days later

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

If pregnant or breastfeeding,ask a health professional before use.

Directions

Adults and children 12 years of age and over:rub on affected area; repeat 3 to 4 times daily

Children under 12 years of age:consult doctor before use.

Other Information

This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive ingredients

Cajeput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil, Paraffin, Petrolatum

Principal Display Panel – 18 g Jar Label

NATURE'S OIL
Muscle Balm

Intense Strength

Muscle Relieving Ointment

Net wt 0.63 oz (18 g)

INGREDIENTS AND APPEARANCE

MUSCLE BALM 
menthol, unspecified form, camphor (synthetic) ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-142
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	110 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	110 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAJUPUT OIL (UNII: J3TO6BUQ37)
CHINESE CINNAMON OIL (UNII: A4WO0626T5)
CLOVE OIL (UNII: 578389D6D0)
PEPPERMINT OIL TERPENELESS (UNII: 4CA0UO1N3Z)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-142-63	18 g in 1 JAR; Type 0: Not a Combination Product	05/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/31/2022

Labeler - Natural Essentials, Inc. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	manufacture(66902-142)