BARKER WELLNESS - PAIN RELIEF BALM - 3.5% (82383-104) DELIST

PAIN RELIEF BALM by

Drug Labeling and Warnings

PAIN RELIEF BALM by is a Otc medication manufactured, distributed, or labeled by BARKER WELLNESS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN RELIEF BALM- menthol ointment 
BARKER WELLNESS 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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BARKER WELLNESS - PAIN RELIEF BALM - 3.5% (82383-104) DELIST

ACTIVE INGREDIENTS

Menthol 3.5%

PURPOSE

TOPICAL ANALGESIC

USES

Provides temporary relief from minor aches and soreness of joints and muscles associated with:

• backaches
• arthritis
• strains
• sprains
• bruises

WARNINGS

For external use only.

When using this product

• Avoid contact with eyes or mucous membranes
• do not apply to wounds or damaged skin
• do not use with other ointments, creams, sprays or liniments
• do not apply to irritated skin or if excessive irritation develops
• do not bandage
• wash hands after use with cool water
• do not use with heating pad or device
• store in a cool dry place

Stop use and ask doctor if: condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

If pregnant or breast feeding: ask a health professional befgore use.

Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediatley

DIRECTIONS

Rub balm gently and thoroughly into the affected area for effective pain relief. Apply cream no more than 3 to 4 times a day.

INACTIVE INGREDIENTS

Olea Europaea (Olive) Fruit Oil, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax. Ricinus Communis (Castor) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Lauryl Laurate, Limnanthes Alba (Meadowfoam) Seed Oil, Broad Spectrum Hemp Extract, Cannabichromene. Cannabigerol, Cannabis Saliva Seed Oil (Hemp Seed Dill. Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol (Vitamin E)

PAIN RELIEF BALM 
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82383-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
COCONUT OIL (UNII: Q9L0O73W7L)
CANDELILLA WAX (UNII: WL0328HX19)
CASTOR OIL (UNII: D5340Y2I9G)
ALMOND OIL (UNII: 66YXD4DKO9)
LAURYL LAURATE (UNII: GPW77G0937)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
HEMP (UNII: TD1MUT01Q7)
CANNABICHROMENE (UNII: K4497H250W)
CANNABIGEROL (UNII: J1K406072N)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
RICE BRAN (UNII: R60QEP13IC)
ROSEMARY (UNII: IJ67X351P9)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82383-104-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2021	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/10/2021	12/31/2022

Labeler - BARKER WELLNESS LLC (108169543)

Revised: 1/2023

Document Id: f26752b8-305b-5f9e-e053-2995a90a7de0

34390-5

Set id: 23080695-433e-4866-bb3f-90537f80b4a9

Version: 11

Effective Time: 20230116