FDA Label for Pain

View Indications, Usage & Precautions

Pain Product Label

The following document was submitted to the FDA by the labeler of this product George L. Rodriguez M.d., Pc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


Otc - Purpose



PURPOSE

PAIN RELIEF


Warnings



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.


Indications & Usage



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.


Dosage & Administration



DIRECTIONS:

FOR EXTERNAL USE ONLY.

ONE PATCH PER DAY. CLEAN SKIN AREA PROR TO USE.

MORE EFFECTIVE AFTER A HOT APPLICATION (EX. BATH/SHOWER).


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN.


Inactive Ingredient



ADHESIVE PLASTER BASE:

ZINC OXIDE.....121.70 MG

OLIVE OIL.....4.90 MG

RESIN.....133.25 MG

RUBBER.....266.50 MG


Package Label.Principal Display Panel




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