EQUILIBRIUM CBD Pain Relief Balm

EQUILIBRIUM CBD Pain Relief Balm by

Drug Labeling and Warnings

EQUILIBRIUM CBD Pain Relief Balm by is a Otc medication manufactured, distributed, or labeled by EQUILIBRIUM NUTRITION PRODUCTS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EQUILIBRIUM CBD PAIN RELIEF BALM- camphor (synthetic), menthol cream 
EQUILIBRIUM NUTRITION PRODUCTS, 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.

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EQUILIBRIUM CBD Pain Relief Balm

Drug Facts

Active Ingredients:

Camphor 11.00%

Menthol 16.00%

Purpose

Topical Analgesic

Uses:

  • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings:

For external use only

Do not 

  • on wounds or damaged skin.

When using this product

  • Avoid contact with the eyes. 
  • Do not bandage tightly.

Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.

Other information:

  • Store at 20-25°C (68-77°F) and protect from moisture. 

Inactive ingredients:

Beeswax, Cannabis Sativa (Broad Spectrum) Hemp Oil, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus Oil, Eugenia Caryophyllus (Clove) Oil, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Simmondsia Chinensis (Jojoba) Oil

Questions?

(844) 634-2587

Package Labeling:

Label

EQUILIBRIUM CBD PAIN RELIEF BALM 
camphor (synthetic), menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82183-251
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)110 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
COCONUT OIL (UNII: Q9L0O73W7L)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
CLOVE (UNII: K48IKT5321)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
TEA TREE OIL (UNII: VIF565UC2G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
JOJOBA OIL (UNII: 724GKU717M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82183-251-0059 mL in 1 JAR; Type 0: Not a Combination Product06/11/202108/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/11/202108/31/2023
Labeler - EQUILIBRIUM NUTRITION PRODUCTS, LLC (056364241)

Revised: 1/2022
Document Id: d58da5d6-f188-04f4-e053-2a95a90a370c
Set id: 308b10eb-ab56-45c1-a853-0048ef8f6664
Version: 2
Effective Time: 20220114