The following Structured Product Label (SPL) was submitted to the FDA by George L. Rodriguez M.d., Pc for the product Pain (NDC 69165-101). 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 otc - active ingredient, otc - purpose, warnings, indications & usage, dosage & administration, otc - keep out of reach of children, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
EACH PIECE 4.2 CM X 6.5 CM PLASTER CONTAINS:
MEDICINAL MATERIAL:
CHLORPHENIRAMINE MALEATE.....13.44 MG
METHYL SALICYLATE.....26.88 MG
SCOPOLIA EXTRACT.....2.69 MG
MENTHOL.....26.88 MG
PEPPERMINT OIL.....26.88 MG
CAMPHOR.....13.44 MG
PHELLODENDRON EXTRACT.....13.44 MG
PURPOSE
PAIN RELIEF
CAUTIONS:
DO NOT USE THIS PRODUCT IF YOU HAVE A SENSITIVE SKIN.
DO NOT APPLY TO THE WOUNDED OR DAMAGED SKIN.
AVOID EYE CONTACT.
DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR. IF IRRITATION PERSISTS, CONSULT A DOCTOR. IF YOU ARE ALLERGIC TO ANY INGREDIENT IN THE PRODUCT, DO NOT USE.
USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.
DIRECTIONS:
FOR EXTERNAL USE ONLY.
ONE PATCH PER DAY. CLEAN SKIN AREA PROR TO USE.
MORE EFFECTIVE AFTER A HOT APPLICATION (EX. BATH/SHOWER).
KEEP OUT OF REACH OF CHILDREN.
ADHESIVE PLASTER BASE:
ZINC OXIDE.....121.70 MG
OLIVE OIL.....4.90 MG
RESIN.....133.25 MG
RUBBER.....266.50 MG
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