Label: MAGNIFICENT MENTHOL COOLING PAIN CREAM- menthol topical analgesic cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76348-421-01, 76348-421-02 - 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 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
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Inactive Ingredients:
Butyrospermum Parkii (Shea
Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol
(CBD) Extract, Cetearyl Alcohol,
Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera
(Coconut) Oil, Deionized Water, Emulsifying Wax,
Hamamelis Virginiana (Witch Hazel) Magnesium Chloride,
Mangifera Indica (Mango) Seed Butter,
Mentha piperita (Peppermint) Leaf Oil, Olea Europaea
(Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Xanthan Gum
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAGNIFICENT MENTHOL COOLING PAIN CREAM
menthol topical analgesic creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-421 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.6 g in 112 g Inactive Ingredients Ingredient Name Strength CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) CORN OIL (UNII: 8470G57WFM) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) LAURETH-7 (UNII: Z95S6G8201) SHEA BUTTER (UNII: K49155WL9Y) XANTHAN GUM (UNII: TTV12P4NEE) WHITE WAX (UNII: 7G1J5DA97F) WITCH HAZEL (UNII: 101I4J0U34) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) PEPPERMINT OIL (UNII: AV092KU4JH) GRAPEFRUIT OIL (UNII: YR377U58W9) CANNABIDIOL (UNII: 19GBJ60SN5) WATER (UNII: 059QF0KO0R) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) COCONUT OIL (UNII: Q9L0O73W7L) OLIVE OIL (UNII: 6UYK2W1W1E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-421-01 112 g in 1 JAR; Type 0: Not a Combination Product 12/06/2018 2 NDC:76348-421-02 112 g in 1 BOX; Type 0: Not a Combination Product 12/06/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/06/2018 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-421)