Xceptor Pain
FDA Label NDC 72519-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Xceptor Llc for the product Xceptor Pain (NDC 72519-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

Otc - 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.

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