Label: XCEPTOL PAIN UNSCENTED- tea salicylate cream

  • 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

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  • ACTIVE INGREDIENTS

    TEA SALICYLATE  10%

  • PURPOSE

    TOPICAL ANALGESIC

  • USES

    TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    KEEP AWAY FROM EYES.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    APPLY SMALL AMOUNT TO AFFECTED AREA AND RUB IN. ADD AS NEEDED.

  • OTHER INFORMATION

    STORE AT 20° - 25°C (68°-77°F)

  • INACTIVE INGREDIENTS

    ALOE BARBADENSIS LEAF JUICE EXTRACT, BENZOIC ACID, BENZYL ALCOHOL, BETA VULGARIS (BEET) ROOT EXTRACT, CANNABIDIOL FROM HEMP, COCOCAPRYLATE/CAPRATE, COCOS NUCIFERA (COCONUT) OIL, COCONUT ALKANES, CYCLODEXTRIN, DISTEARDIMONIUM HECTORITE, GLYCERIN, MAGNESIUM SULFATE, POLYGLYCERYL-3 DIISOSTEARATE, POLYGLYCERYL-3 POLYRICINOLEATE, SHEA BUTTER ETHYL ESTERS, SORBIC ACID, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, XANTHAN GUM, WATER

  • QUESTIONS / COMMENTS?

    PLEASE CALL US AT (760) 710-0510

  • PRINCIPAL DISPLAY PANEL

    01b UC_Xceptol Pain Cream_Unscented_50mL

  • INGREDIENTS AND APPEARANCE
    XCEPTOL PAIN  UNSCENTED
    tea salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72519-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BETAINE (UNII: 3SCV180C9W)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    BETADEX (UNII: JV039JZZ3A)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    QUATERNIUM-91 (UNII: 00J8H295NB)  
    SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBIC ACID (UNII: X045WJ989B)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72519-105-2130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/10/2020
    2NDC:72519-105-2250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/10/2020
    3NDC:72519-105-111 mL in 1 PACKET; Type 0: Not a Combination Product06/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/10/2020
    Labeler - XCEPTOR LLC (081207471)
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