MUSCLE BALM- menthol, unspecified form, camphor (synthetic) ointment 
Natural Essentials, Inc.

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.

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Drug Facts

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:

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)

Figure
MUSCLE BALM 
menthol, unspecified form, camphor (synthetic) ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-142
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM110 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)110 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-142-6318 g in 1 JAR; Type 0: Not a Combination Product05/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/31/2022
Labeler - Natural Essentials, Inc. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-142)

Revised: 5/2022
Document Id: 77249d6f-9e7f-44da-b046-8f0fe4641193
Set id: 16918ba3-2e07-4232-9ed3-4c7751796cd2
Version: 1
Effective Time: 20220531
 
Natural Essentials, Inc.