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

PAIN RELIEF  3%
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82383-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82383-101-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/10/2021	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: f267393d-4110-f400-e053-2995a90a7aa2

34390-5

Set id: a0fdcd9d-74cc-4d80-8ac6-d479d6a2859f

Version: 12

Effective Time: 20230116