XCEPTOL PAIN UNSCENTED- tea salicylate 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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XCEPTOL PAIN CREAM - UNSCENTED

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.

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

01b UC_Xceptol Pain Cream_Unscented_50mL

XCEPTOL PAIN UNSCENTED
tea salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72519-105
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72519-105-21	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/10/2020
2	NDC:72519-105-22	50 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/10/2020
3	NDC:72519-105-11	1 mL in 1 PACKET; Type 0: Not a Combination Product	06/10/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/10/2020

Labeler - XCEPTOR LLC (081207471)