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  5. Label Information: Allevess

FDA Label for Allevess

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSES:
    3. USES:
    4. WARNINGS:
    5. WHEN USING THIS PRODUCT
    6. DO NOT USE
    7. STOP USE AND ASK A DOCTOR
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS:
    11. OTHER INGREDIENTS:
    12. OTC - QUESTIONS
    13. PRINCIPAL DISPLAY PANEL

Allevess Product Label

The following document was submitted to the FDA by the labeler of this product Api Solutions, Inc.. 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.

Active Ingredients:



MENTHOL  5.00%
CAPSAICIN  0.05%


Purposes:



TOPICAL ANALGESIC
TOPICAL ANALGESIC


Uses:



FOR TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF THE MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, BRUISES AND SPRAINS.


Warnings:



FOR EXTERNAL USE ONLY.


When Using This Product



∙ USE ONLY AS DIRECTED


Do Not Use



DO NOT USE ON, AND AVOID CONTACT WITH, FACE, SCALP, EYES, MOUTH, AND MUCOUS MEMBRANES ∙ DO NOT USE ON WOUNDS OR DAMAGED OR SENSITIVE SKIN ∙ DO NOT USE IN COMBINATION WITH ANY EXTERNAL HEAT SOURCE (HEATING PAD, ETC.) OR FOR 1 HOUR BEFORE OR AFTER BATHING OR SHOWERING ∙ DO NOT USE IN COMBINATION WITH ANY COMPRESSION (BANDAGE, WRAP, BRACE,  STOCKING, SOCK, OR SIMILAR DEVICE OR GARMENT) ∙ DO NOT USE IN COMBINATION WITH ANY OTHER EXTERNAL ANALGESIC PRODUCTS.


Stop Use And Ask A Doctor



STOP USE AND ASK A DOCTOR IF ∙ EXCESSIVE REDNESS, BURNING, SWELLING, IRRITATION, OR DISCOMFORT DEVELOPS IN THE SKIN, EYES, MOUH OR MUCOUS MEMBRANES ∙ CONDITION WORSENS ∙ PAIN PERSISTS FOR MORE THAN 7 DAYS ∙ SYMPTOMS CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS


If Pregnant Or Breast-Feeding,



ASK A DOCTOR BEFORE USE.


Keep Out Of Reach Of Children.



IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


Directions:



ADULTS AND CHILDREN 16 YEARS AND OVER: APPLY DIRECTLY TO AFFECTED AREA OF PAIN; CHANGE PATCH 1 TO 2 TIMES DAILY, OR AS DIRECTED BY A DOCTOR ∙ CHILDREN UNDER 16 YEARS: ASK A DOCTOR BEFORE USING

HOW TO APPLY:
− CLEAN AND DRY AFFECTED AREA - TEAR OPEN POUCH AND REMOVE ONE PATCH
− REMOVE PROTECTIVE FILM AND APPLY DIRECTLY TO AFFECTED AREA OF PAIN
− RESEAL POUCH CONTAINING UNUSED PATCHES AFTER EACH USE
− WASH HANDS WITH SOAP AND WATER AFTER APPLYING


Other Ingredients:



ACRYLIC ACID, ALUMINUM HYDROXIDE, GLYCERIN, METHYL ACRYLATE, CARMELLOSE SODIUM, 2-ETHYLHEXYL ACRYLATE, TARTARIC ACID, POLYACRYLATE, POLYACRYLIC ACID, WATER, SODIUM POLYACRYLATE


Otc - Questions



DISTRIBUTED BY:
A.P.I. SOLUTIONS
DAPHNE, AL 36526
FOR QUESTIONS OR COMMENTS PLEASE CALL 855-878-1489


Principal Display Panel



ALLEVESS PATCH

TOPICAL ANALGESIC PATCH - MENTHOL 5%, CAPSAICIN 0.05%
QTY: 15 PATCHES: (5 PER RESEALABLE POUCH) × 3

LOT:
EXP:
NDC: 46144-162-01


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