DR GREENES GOOD STUFF PAIN RELIEF ROLL ON: Package Insert and Label Information

DR GREENES GOOD STUFF PAIN RELIEF ROLL ON- menthol liquid
Dr. Greene’s Good Stuff, 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.

DRUG FACTS

Active Ingredient

Menthol 3.00%

Topical Analgesic

Indications

For the temporary relief of minor aches and pains of the muscles and joints asscoated with arthritis, simple backache, sprains, bruises, and strains.

Warnings

- For external use only.

- Avoid contact with eyes.

- If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

- If swallowed, consult physician.

- Do not apply to wounds or damaged skin.

- Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions

- Adults and children two-years of age or older. Apply to affected area not more than three to four times daily.

- Children under two-years of age consult a physican.

Additional Information

Store at room temperature.

Other Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Cannabis Sativa (Full Spectrum Hemp) Oil, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Isopropyl Alcohol, Isopropyl Myristate, Methylsulfonylmethane (MSM), Phenoxyethanol, Sorbitan Olivate, Stearic Acid, Xanthan Gum.

Package Labeling:

Label
(click image for full-size original)

DR GREENES GOOD STUFF PAIN RELIEF ROLL ON
menthol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73334-155
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
WATER
ARNICA MONTANA FLOWER
INDIAN FRANKINCENSE
GREEN TEA LEAF
CAPRYLYL GLYCOL
CETEARYL OLIVATE
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
GLUCOSAMINE SULFATE
GLYCERIN
GLYCERYL MONOSTEARATE
HELIANTHUS ANNUUS FLOWERING TOP
ISOPROPYL ALCOHOL
ISOPROPYL MYRISTATE
DIMETHYL SULFONE
PHENOXYETHANOL
SORBITAN OLIVATE
STEARIC ACID
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73334-155-03 88.7 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 09/01/2019
Labeler — Dr. Greene’s Good Stuff, LLC (010695496)

Revised: 09/2019 Dr. Greene’s Good Stuff, LLC

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