Label: JUST CHILL PAIN RELIEF- menthol 5 percent liquid
- NDC Code(s): 76348-690-01
- Packager: RENU LABORATORIES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated September 20, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
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, Menth Piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Hamamelis Virginiana (Witch Hazel)
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
JUST CHILL PAIN RELIEF
menthol 5 percent liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-690 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.4 g in 28 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E) PEPPERMINT OIL (UNII: AV092KU4JH) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) MAGNESIUM OROTATE (UNII: GI96W46M5A) LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG) MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ARNICA MONTANA (UNII: O80TY208ZW) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741) ISOPROPYL ALCOHOL (UNII: ND2M416302) CANNABIDIOL (UNII: 19GBJ60SN5) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J) WITCH HAZEL (UNII: 101I4J0U34) MAGNESIUM MYRISTATE (UNII: Z1917F0578) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-690-01 28 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 09/20/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/20/2021 Labeler - RENU LABORATORIES, INC. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-690)