Label: XCEPTOR PAIN- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72519-101-11, 72519-101-21 - Packager: XCEPTOR LLC
- 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 July 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
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WARNINGS
FOR EXTERNAL USE ONLY.
ALLERGY ALERT: IF ALLERGIC TO ASPERIN OR SALICYLATES OR MENTHOL CONSULT A PHYSICIAN PRIOR TO USE.
DO NOT USE:
- ON WOUNDS OR DAMAGED SKIN
- WITH A HEATING PAD
- ON A CHILD UNDER 12 WITH ARTHRITIS-LIKE CONDITIONS
- ON INFLAMED SKIN
- WITH OTHER TOPICAL PAIN RELIEF PRODUCTS
WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES OR MUCOUS MEMBRANES, AVOID EXPOSURE TO SUNLIGHT.
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
WATER, COCONUT ALKANES, COC-CAPRYLATE/CAPRATE, GLYCERINE, ALOE BARBADENSIS LEAF JUICE, CANNABIS SATIVA SEED OIL, DISTEARDIMONIUM HECTORITE, CAPRYLIC/CAPRIC TRIGLYCERIDES, SODIUM CHLORIDE, CYCLODEXTRIN, POLYGLYCERYL-3 POLYRICINOLEATE, POLYGLYCERYL-3 DIISOSTEARATE, BETAINE, CANNABIDOIL (FROM HEMP), COCOS NUCIFERA (COCONUT) OIL, HYALURONIC ACID, LECITHIN, LINOLEIC ACID, OLEIC ACID, PALMITIC ACID, PHENOXYETHANOL, PHYTOSTEARYL CANOLA GLYCERIDES, POTASSIUM SORBATE, SODIUM BENZOATE, SORBIC ACID, STEARIC ACID, TOCOPHEROL, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, XANTHAN GUM.
- QUESTIONS / COMMENTS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
XCEPTOR PAIN
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72519-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCONUT ALKANES (UNII: 1E5KJY107T) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SODIUM CHLORIDE (UNII: 451W47IQ8X) BETADEX (UNII: JV039JZZ3A) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) BETAINE (UNII: 3SCV180C9W) CANNABIDIOL (UNII: 19GBJ60SN5) COCONUT OIL (UNII: Q9L0O73W7L) HYALURONIC ACID (UNII: S270N0TRQY) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) LINOLEIC ACID (UNII: 9KJL21T0QJ) OLEIC ACID (UNII: 2UMI9U37CP) PALMITIC ACID (UNII: 2V16EO95H1) PHENOXYETHANOL (UNII: HIE492ZZ3T) CANOLA OIL (UNII: 331KBJ17RK) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBIC ACID (UNII: X045WJ989B) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72519-101-11 90 mL in 1 TUBE; Type 0: Not a Combination Product 10/04/2018 2 NDC:72519-101-21 30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 03/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/04/2018 Labeler - XCEPTOR LLC (081207471)
