XCEPTOR PAIN- menthol cream 
XCEPTOR LLC

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.

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XCEPTOR PAIN CREAM

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:

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES OR MUCOUS MEMBRANES, AVOID EXPOSURE TO SUNLIGHT.

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

Pain Cream LBL

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)

Revised: 7/2020
Document Id: 58b3f755-b248-4e52-af3e-905175d70b94
Set id: d09dd40d-166b-4ce5-b22e-f6db17dce312
Version: 6
Effective Time: 20200715
 
XCEPTOR LLC