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)

01b UC_Pain Relief Balm_3.5pct_Box_Front

01b UC_Pain Relief Balm_3.5pct_Box_Back

PAIN RELIEF BALM 
menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82383-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82383-104-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/202112/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/10/202112/31/2022
Labeler - BARKER WELLNESS LLC (108169543)

Revised: 1/2023
 

Trademark Results [PAIN RELIEF BALM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PAIN RELIEF BALM
PAIN RELIEF BALM
90525286 not registered Live/Pending
Yohan Bathiya Karunarathne
2021-02-11

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