FDA.reportPublic FDA data

Retadolor™ CREAM

Manufacturer
LACAR SALES & MARKETING INC. | Concept Laboratories, Inc.
Effective date
2017-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:09

Label at a glance#

ProductRetadolor
Active ingredientMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)
Label structure7 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strain sprains bruises

Dosage and administration

Apply liberally to affected area not more than 4 times daily unless otherwise directed by your physician or pharmacist Gently massage into the skin until fully absorbed Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Menthol 12%Pain Relieving
Camphor 6%Pain Relieving

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strain
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly

OTC - WHEN USING SECTION

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Flammable

SPL UNCLASSIFIED SECTION

Keep from heat and flame.

OTC - STOP USE SECTION

Discontinue 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

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
  • if pregnant or nursing, seek the advice of a health professional before using

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally to affected area not more than 4 times daily unless otherwise directed by your physician or pharmacist
  • Gently massage into the skin until fully absorbed
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate.

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RETADOLOR™
The Anti-Pain™

PENETRATING COOL THERAPY CREAM

Topical Analgesic for the Relief of
TENSION, STRAINS, SPRAINS
& MUSCLE PAIN

Contains Powerful
Menthol & Camphor
with Vanishing
Scent

ANTI-INFLAMMATORY
OMEGA
3, 6 & 9
with
IcePearls

NET WT. 3 OZ (85g)

Principal Display Panel - 85 g Bottle Label
Principal Display Panel - 85 g Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1150970camphor 6 % / menthol 12 % Topical CreamPSN1
1872903RETADOLOR The Anti-Pain 6 % / 12 % Topical CreamPSN1
1872903camphor 60 MG/ML / menthol 120 MG/ML Topical Cream [Retadolor The Anti-Pain]SBD1
1150970camphor 60 MG/ML / menthol 120 MG/ML Topical CreamSCD1
1150970camphor 6 % / menthol 12 % Topical CreamSY1
1872903Retadolor The Anti-Pain (camphor 6 % / menthol 12 % ) Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69279-241-132020-01-31C16284748780-19d75b9d0-28bd-f424-e053-dadaa90a57ceRetadolor™ CREAM
69279-241-442020-01-31C16284748780-19d75b9d0-28bd-f424-e053-dadaa90a57ceRetadolor™ CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69279-241-13Retadolor85 g in 1 BOTTLECREAM851
69279-241-44Retadolor113 g in 1 BOTTLECREAM1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69279-241RETADOLOR (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [LACAR SALES & MARKETING INC.]1Legacy NDC, 2 package rows20170308_5245b855-2a5c-4cbc-8523-c3dc317b53f1.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69279-24169279-241-13, 69279-241-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
Water059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEPPERMINT OILAV092KU4JHIACT
ALCOHOL3K9958V90MIACT
STARCH, CORNO8232NY3SJIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
LINSEED OIL84XB4DV00WIACT
ROSEMARY OIL8LGU7VM393IACT
ACAI OILZ0W6766A2WIACT
PPG-2 HYDROXYETHYL COCAMIDE34N07GUJ3XIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
ETHYL MENTHANE CARBOXAMIDE6S7S02945HIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
LAURYL LAURATEGPW77G0937IACT
HYDRATED SILICAY6O7T4G8P9IACT

Source Document#

Source XML

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
226dbfdf-95be-4082-a8d4-be72c4b1392e5245b855-2a5c-4cbc-8523-c3dc317b53f12017-03-07WarningsExact identifier
spl id: 226dbfdf-95be-4082-a8d4-be72c4b1392e
spl set id: 5245b855-2a5c-4cbc-8523-c3dc317b53f1

Reported adverse events (FAERS/openFDA)#

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