OTC Medication Information: MAG 5 PT WARMING FORMULA ROLL ON

MAG 5 PT WARMING FORMULA ROLL ON- menthol liquid
RENU LABORATORIES, INC.

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.

Menthol 5%

Topical Analgesic

For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

For external use only

Do not bandage tightly

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use with heating pads or other heating devices.

Stop use and ask a doctor if

  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist
  • children under 12 years of age, do not use, consult a doctor.

Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Hydroxyethyl Cellulose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Virginiana Hamamelis (Witch Hazel)

MAG5 PT COOLING FORMULA ROLL ON LABEL AND BOX

PRODUCT LABEL AND BOX

cooling roll on label
(click image for full-size original)
MAG5 PT COOL ROLL ON BOX
(click image for full-size original)
MAG 5 PT WARMING FORMULA ROLL ON
menthol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-515
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 4.2 g in 84 g
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL
SODIUM BENZOATE
POLYSORBATE 80
GRAPEFRUIT
LOBELIA INFLATA LEAF
MAGNESIUM MYRISTATE
TABASCO PEPPER
CANNABIS SATIVA SEED OIL
MAGNESIUM OROTATE
WITCH HAZEL
ARNICA MONTANA FLOWER
CANNABIDIOL
MAGNESIUM GLUCONATE
HIPPOPHAE RHAMNOIDES FRUIT OIL
MAGNESIUM SULFATE, UNSPECIFIED
MAGNESIUM CHLORIDE
WATER
PEPPERMINT OIL
HIPPOPHAE RHAMNOIDES SEED OIL
METHYLCELLULOSE, UNSPECIFIED
POTASSIUM SORBATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76348-515-01 1 BOTTLE, WITH APPLICATOR in 1 BOX contains a BOTTLE, WITH APPLICATOR (76348-515-03)
1 NDC:76348-515-03 84 g in 1 BOTTLE, WITH APPLICATOR This package is contained within the BOX (76348-515-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/19/2019
Labeler — RENU LABORATORIES, INC. (945739449)
Establishment
Name Address ID/FEI Operations
RENU LABORATORIES, INC. 945739449 manufacture (76348-515)

Revised: 05/2020 RENU LABORATORIES, INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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