Rematex Pain Relieiving Cream

Manufacturer
Home Aide Diagnostics, Inc. | Zhejiang Bangli Medical Products Co. Ltd
Effective date
2015-07-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:42:59

Label at a glance#

ProductRematex
Active ingredientMENTHOL, METHYL SALICYLATE, CAPSAICIN
Label structure10 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REMATEX.jpgREMATEX.jpg

OTC - PURPOSE SECTION

PURPOSE: Topical analgesic

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS


Mehyl Salicylate 30% ------------------------------------------------------------------------------------------------ Counterirritant
Menthol 6% --------------------------------------------------------------------------------------------------------- Topical analgesic
Capsaicin 0.035% ------------------------------------------------------------------------------------------------- Topical analgesic

INDICATIONS & USAGE SECTION

INDICATIONS
For the temporary relief of minor pain of muscles and joints associated with:

  • Arthritis
  • Simple Backache
  • Strains
  • Sprains
  • Bruises

WARNINGS SECTION

WARNINGS
FOR EXTERNAL USE ONLY.

  • Use only as directed
  • Do not bandage tightly
  • Do not use with a heating pad
  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds, damaged, broken or irritated skin
  • A transient burning sensation may occur upon application but generally disappears in several days
  • If severe burning sensation occurs, discontinue use immediately and call a doctor
  • Do not expose the area treated with product to heat or direct sunlight

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • Adults and children over 18 years:
  • Apply generously to affected area
  • Massage into painful area until thoroughly absorbed into skin
  • Repeat as necessary, not more than 3-4 times daily.
  • Wash hands with soap and water immediately after use.
  • Children 18 years or younger: ask a doctor

Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF:

  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present or irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant of breast-feeding, ask a healthcare professional before use

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose Sodium; water;

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1655506capsaicin 0.035 % / menthol 6 % / methyl salicylate 30 % Topical CreamPSN4
1655506capsaicin 0.35 MG/ML / menthol 60 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD4
1655506capsaicin 0.035 % / menthol 6 % / methyl salicylate 30 % Topical CreamSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69379-035-012020-01-31C16284748780-19d75b9d0-f6a0-f424-e053-dadaa90a57ceRematex Pain Relieiving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69379-035-01Rematex120 g in 1 BOTTLE, PUMPCREAM1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69379-035REMATEX (REMATEX PAIN RELIEVINGCREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]4Legacy NDC, 1 package rows20150711_1a8b55af-1cf0-1567-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM4
MENTHOLACTIVE INGREDIENTL7T10EIP3A4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y4
CAPSAICINACTIVE MOIETYS07O44R1ZM4
MENTHOLACTIVE MOIETYL7T10EIP3A4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69379-03569379-035-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1a8b55af-1cf1-1567-e054-00144ff88e881a8b55af-1cf0-1567-e054-00144ff88e882015-07-10WarningsExact identifier
spl id: 1a8b55af-1cf1-1567-e054-00144ff88e88
spl set id: 1a8b55af-1cf0-1567-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.