Label: INSPIRATION ACADEMY MENTHOL COOLING PAIN CREAM- menthol 5 percent cream
- NDC Code(s): 76348-900-01, 76348-900-04
- 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 3, 2022
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- QUESTIONS
- STOP USE
- WHEN USING
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter,
Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water,
Emulsifying Wax, Fragrance, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil,
Laureth-7, Lobelia Inflata (Lobelia) Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Leaf Oil, Olea europaea (Olive) Oil,
Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Xanthan Gum.
- INDICATIONS & USAGE
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INSPIRATION ACADEMY MENTHOL COOLING PAIN CREAM
menthol 5 percent creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-900 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 ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741) PEG-100 STEARATE (UNII: YD01N1999R) HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J) SHEA BUTTER (UNII: K49155WL9Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) WATER (UNII: 059QF0KO0R) WHITE WAX (UNII: 7G1J5DA97F) WITCH HAZEL (UNII: 101I4J0U34) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) COCONUT OIL (UNII: Q9L0O73W7L) LAURETH-7 (UNII: Z95S6G8201) LOBELIA INFLATA (UNII: 9PP1T3TC5U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) MAGNESIUM MYRISTATE (UNII: Z1917F0578) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEPPERMINT OIL (UNII: AV092KU4JH) CORN OIL (UNII: 8470G57WFM) OLIVE OIL (UNII: 6UYK2W1W1E) XANTHAN GUM (UNII: TTV12P4NEE) MAGNESIUM OROTATE (UNII: GI96W46M5A) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-900-01 1 in 1 BOX 11/08/2021 1 NDC:76348-900-04 112 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/08/2021 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations RENU LABORATORIES, INC. 945739449 manufacture(76348-900)