Indications and uses
FOR TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF THE MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, BRUISES AND SPRAINS.
API Solutions - Allevess Patch
- Manufacturer
- API Solutions, Inc.
- Effective date
- 2015-12-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:44:16
Label at a glance#
ProductALLEVESS
Active ingredientMENTHOL, CAPSAICIN
Label structure8 sections
Dosage and administration
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 WIT...
Contacts and useful links#
Label contents#
Full prescribing information#
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 SECTION
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
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 46144-162-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-da5a-f424-e053-dadaa90a57ce | API Solutions - Allevess Patch |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 46144-162-01 | ALLEVESS | 3 in 1 BOX | PATCH | 3 | 1 | |
| 46144-162-01 | ALLEVESS | 5 in 1 POUCH | PATCH | 5 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 46144-162-01 | EA - Each | 46144-162 | 99e3ad10-29d3-4bca-9be7-e2df066bce25 | 1 | 2016-11-08 |
Products#
Every source-derived product name is available through these pages.
- ALLEVESS
- MENTHOL, CAPSAICIN
- MENTHOL
- CAPSAICIN
- Acrylic Acid
- Aluminum Hydroxide
- Glycerin
- Methyl Acrylate
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- 2-Ethylhexyl Acrylate
- Tartaric Acid
- POLYACRYLIC ACID (8000 MW)
- Water
- SODIUM POLYACRYLATE (2500000 MW)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 46144-162 | 46144-162-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| CAPSAICIN | S07O44R1ZM | ACTIB |
| Acrylic Acid | J94PBK7X8S | IACT |
| Aluminum Hydroxide | 5QB0T2IUN0 | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Methyl Acrylate | WC487PR91H | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| 2-Ethylhexyl Acrylate | HR49R9S6XG | IACT |
| Tartaric Acid | W4888I119H | IACT |
| POLYACRYLIC ACID (8000 MW) | 73861X4K5F | IACT |
| Water | 059QF0KO0R | IACT |
| SODIUM POLYACRYLATE (2500000 MW) | 05I15JNI2J | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ea916cea-85dd-4b38-8475-a33ab762b9b5 | 1982db88-d00d-4ba7-ae87-190799556709 | 2015-12-02 | Warnings | ea916cea-85dd-4b38-8475-a33ab762b9b5 1982db88-d00d-4ba7-ae87-190799556709 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.