PAIN RELIEF 2%: Package Insert and Label Information

PAIN RELIEF 2%- 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.

ACTIVE INGREDIENTS

Menthol 2%

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 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

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PAIN RELIEF 2%
menthol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82383-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
.ALPHA.-BISABOLOL, (+/-)-
CANNABIS SATIVA SEED OIL
SHEA BUTTER
CANNABICHROMENE
CANNABIGEROL
CAPRYLHYDROXAMIC ACID
TRICAPRIN
CETOSTEARYL ALCOHOL
CETEARYL OLIVATE
CETYL ESTERS WAX
CETYL PALMITATE
CUCUMBER
EUCALYPTUS OIL
GLYCERYL MONOCAPRYLATE
GLYCERIN
HELIANTHUS ANNUUS FLOWERING TOP
PEPPERMINT OIL
RICE BRAN
PANTHENOL
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)
ROSEMARY
JOJOBA OIL
HYALURONATE SODIUM
SORBITAN OLIVATE
TOCOPHEROL
WATER
XANTHAN GUM
SUNFLOWER OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82383-102-01 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/10/2021
Labeler — BARKER WELLNESS LLC (108169543)

Revised: 11/2021 BARKER WELLNESS LLC

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