Label: OP6 MENTHOL WARMING PAIN CREAM- menthol cream
- NDC Code(s): 76348-681-01, 76348-681-04
- 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 September 14, 2021
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- 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
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract and proprietary terpene blend (Myrcene, b-Caryophyllene, d-Limonene, Humulene, Terpinolene, a-Pinene, Linalool, b-Pinene, Valencene, 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, Olea Europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100, Phenoxyethanol, Polyacrylamide, Stearic Acid
- Uses
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OP6 MENTHOL WARMING PAIN CREAM
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-681 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 TABASCO PEPPER (UNII: J1M3NA843L) .BETA.-PINENE (UNII: 4MS8VHZ1HJ) HUMULENE (UNII: 54W56MD2WD) TERPINOLENE (UNII: N9830X5KSL) LINALOOL, (+)- (UNII: F4VNO44C09) VALENCENE (UNII: 96H21P91IG) 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) 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) MYRCENE (UNII: 3M39CZS25B) LIMONENE, (+)- (UNII: GFD7C86Q1W) CARYOPHYLLENE (UNII: BHW853AU9H) .ALPHA.-PINENE (UNII: JPF3YI7O34) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-681-01 1 in 1 BOX 09/14/2021 1 NDC:76348-681-04 112 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 09/14/2021 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-681)
