FDA.reportPublic FDA data

Rotex Pain Relieving Cream

Manufacturer
Home Aide Diagnostics, Inc. | Zhejiang Bangli Medical Products Co. Ltd
Effective date
2015-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:15

Label at a glance#

ProductRotex
Active ingredientMETHYL SALICYLATE, MENTHOL, CAPSAICIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

PURPOSE: Topical analgesic

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS
Methyl Salicylate 35% ----------------------------- Counterirritant
Capsaicin 0.038% ----------------------------------- Counterirritant
Menthol 4% ---------------------------------------- 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; odium; water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rotex.jpgRotex.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1660761capsaicin 0.038 % / menthol 4 % / methyl salicylate 35 % Topical CreamPSN1
1660761capsaicin 0.38 MG/ML / menthol 40 MG/ML / methyl salicylate 350 MG/ML Topical CreamSCD1
1660761capsaicin 0.038 % / menthol 4 % / methyl salicylate 35 % Topical CreamSY1

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
69379-038-012020-01-31C16284748780-19d75b9d0-7a1a-f424-e053-dadaa90a57ceRotex Pain Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69379-038-01Rotex120 g in 1 BOTTLE, PLASTICCREAM1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69379-038ROTEX (ROTEX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]1Legacy NDC, 1 package rows20150810_1c834710-1286-3266-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69379-038-01GM - Gram69379-038cdf21bf8-e16c-4804-b79f-f42496a7cfba12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
CAPSAICINACTIVE MOIETYS07O44R1ZM1
MENTHOLACTIVE MOIETYL7T10EIP3A1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

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
69379-03869379-038-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
CAPSAICINS07O44R1ZMACTIB

Source Document#

Source XML

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 ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact 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 ACID4ELV7Z65APEMULSION / ORALNAExact 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 ACID4ELV7Z65APLOTION / TOPICAL80 mgExact 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 ACID4ELV7Z65APSOLUTION / TOPICALNAExact 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 / TOPICAL190 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 ACID4ELV7Z65APCAPSULE / ORAL90 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 ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 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 ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact 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 ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %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 ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 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 ACID4ELV7Z65APTABLET / BUCCAL6 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
1c834710-1287-3266-e054-00144ff8d46c1c834710-1286-3266-e054-00144ff8d46c2015-08-04WarningsExact identifier
spl id: 1c834710-1287-3266-e054-00144ff8d46c
spl set id: 1c834710-1286-3266-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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