XCEPTOR PAIN (MENTHOL) CREAM [XCEPTOR LLC]

XCEPTOR PAIN (MENTHOL) CREAM [XCEPTOR LLC]
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NDC 72519-101-11, 72519-101-21
Set ID d09dd40d-166b-4ce5-b22e-f6db17dce312
Category HUMAN OTC DRUG LABEL
Packager XCEPTOR LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENTS

    METHYL SALICYLATE  10%

  • PURPOSE

    TOPICAL ANALGESIC

  • USES

    TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.

  • 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

    KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    ADULTS AND CHILDREN 12 YRS AND OLDER APPLY A BEAD OF PRODUCT OVER AFFECTED AREA, RUB IN. SAFE TO ADD MORE FOR ADDITIONAL RELIEF. CHILDREN UNDER 12 CONSULT A PHYSICIAN.

  • OTHER INFORMATION

    STORE AT 20° - 25°C (68°-77°F)

  • 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?

    PLEASE CALL US AT (760) 710-0510

  • PRINCIPAL DISPLAY PANEL

    Pain Cream LBL

  • INGREDIENTS AND APPEARANCE
    XCEPTOR PAIN 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72519-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72519-101-1190 mL in 1 TUBE; Type 0: Not a Combination Product10/04/2018
    2NDC:72519-101-2130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/04/2018
    Labeler - XCEPTOR LLC (081207471)

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