Label: ELEVATE HEATING THERAPY- menthol cream
- NDC Code(s): 76348-458-02
- 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 January 13, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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Warnings
For external use only
When using this product do not bandage tightly
avoid contact with eye
do not apply to wounds or damaged skin
Stop use and ask doctor
if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep out of reach of children
If swallowed get medical help or contact Poison Control Center right away
- PURPOSE
- QUESTIONS
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Glyceryl Stearate, Grapefruit Oil, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Mint Oil, Olea Europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100, Phenoxyethanol, Polyacrylamide, Stearic Acid
- STATEMENT OF IDENTITY
- Uses
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ELEVATE HEATING THERAPY
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-458 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.8 g in 56 g Inactive Ingredients Ingredient Name Strength CAPSICUM (UNII: 00UK7646FG) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) COCONUT OIL (UNII: Q9L0O73W7L) WHITE WAX (UNII: 7G1J5DA97F) SHEA BUTTER (UNII: K49155WL9Y) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) OLIVE OIL (UNII: 6UYK2W1W1E) STEARIC ACID (UNII: 4ELV7Z65AP) GRAPEFRUIT OIL (UNII: YR377U58W9) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) LAURETH-7 (UNII: Z95S6G8201) WITCH HAZEL (UNII: 101I4J0U34) CANNABIDIOL (UNII: 19GBJ60SN5) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921) CORN OIL (UNII: 8470G57WFM) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) PEPPERMINT OIL (UNII: AV092KU4JH) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-458-02 56 g in 1 TUBE; Type 0: Not a Combination Product 11/04/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/04/2019 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-458)
