BARKER WELLNESS - PAIN RELIEF CREAM - 3% (82383-101) DELIST

PAIN RELIEF by

Drug Labeling and Warnings

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

Drug Details [pdf]

PAIN RELIEF 3%- menthol cream 
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 CREAM - 3% (82383-101) DELIST

ACTIVE INGREDIENTS

Menthol 3%

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 immediately.

DIRECTIONS

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

INACTIVE INGREDIENTS

Aloe Barbadensis (Aloe Vera) Leaf Juice, Bisabolol, Broad Spectrum Hemp Oil Extract, Butyrospermum Parkii (Shea) Butter, Cannabichromene, Cannabigerol, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Esters, Cetyl Palmitate, Cucumis Sativus (Cucumber) Fruit Extract, Eucalyptus Globulus Leaf Oil, Glyceryl Caprylate, Glycerin. Helianthus Annuus (Sunflower) Extract. Helianthus Annuus (Sunflower) Seed Oil. Mentha Piperita (Peppermint) Oil, Oryza Sativa (Rice) Bran Extract, Panthenol, Polyacrylate Crosspolymer-6, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hyaluronate, Sorbitan Olivate, Tocopherol, Water, Xanthan Gum

01b UC_Pain Relief Cream_3pct_Front

01b UC_Pain Relief Cream_3pct_Back

PAIN RELIEF  3%
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82383-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CANNABICHROMENE (UNII: K4497H250W)  
CANNABIGEROL (UNII: J1K406072N)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CUCUMBER (UNII: YY7C30VXJT)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERIN (UNII: PDC6A3C0OX)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
RICE BRAN (UNII: R60QEP13IC)  
PANTHENOL (UNII: WV9CM0O67Z)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
ROSEMARY (UNII: IJ67X351P9)  
JOJOBA OIL (UNII: 724GKU717M)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
SHEA BUTTER (UNII: K49155WL9Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82383-101-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product11/10/202112/31/2022
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]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PAIN RELIEF
PAIN RELIEF
97238381 not registered Live/Pending
Liu, Caiqing
2022-01-25

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