FDA.reportPublic FDA data

Pain Relief Cream

Manufacturer
Cosmetic Specialty labs, Inc.
Effective date
2018-10-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:07

Label at a glance#

ProductPain Relief Cream Topical Analgesic
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Dosage and administration

adults and children over 2 years: apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 4 times daily children 2 years or younger: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 6.0%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

for external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 2 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 2 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica montana, Butylene glycol, Calendula officinalis (Marigold), Capryl glycol, Calpsicum grutescens, Carbomer, Cantharius tinctorious (Safflower) Seed Oil, Centaureacyanus (Cornflower), Cetearyl alcohol, Cetyl alcohol, Chamomila recutita (Matricaria Chamomila), Coriandrum sativum (Coriander), Hamamelis virginiana (Witch Hazel), Bark/Leaf/Twig, Hypericum perforatum (St. John's Wort), Industrial Hemp geed oil, Methylsulfonylmethane, Phenoxyethanol, Purified water,Salix alba (Willow Bark), SD Alcohol40, Sorbitol, Tetrasodium EDTA, Tilla cordata (Lime Tree), Triethanolamine

SPL UNCLASSIFIED SECTION

Manufactured for: Good Energy Products

a DBA of Special Effort Ltd. Austin, TX 78701

www.goodenergyproducts.com (800) 698-ALOE

Made in the U.S.A.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP Drtug factsPDP Drtug facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1488306menthol 6 % Topical CreamPSN1
1488306menthol 60 MG/ML Topical CreamSCD1
1488306menthol 6 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-222-032024-01-30C16284748780-11030e365-6ab9-111a-e063-dadaa90a10e2Dr. Wolfe's OTC Energized Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-222-03Pain Relief CreamTopical Analgesic81 mL in 1 TUBECREAM811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-222PAIN RELIEF CREAM TOPICAL ANALGESIC (MENTHOL 6%) CREAM [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 1 package rows20181101_798703ab-16ba-6da3-e053-2991aa0a4688.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-22258133-222-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
TRIETHANOLAMINE LAURYLAMINOPROPIONATE793J74ICPWIACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPSICUM00UK7646FGIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
CENTAUREA CYANUS FLOWERQZ239038YCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CORIANDER OIL7626GC95E5IACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SALIX ALBA BARK205MXS71H7IACT
ISOPROPYL ALCOHOLND2M416302IACT
SORBITOL506T60A25RIACT
TILIA X EUROPAEA FLOWERNHV2K1OUDHIACT
MENTHOLL7T10EIP3AACTIB
HEMPTD1MUT01Q7IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYPERICUM PERFORATUMXK4IUX8MNBIACT
3-((3-CHLOROPHENYL)(4-(METHYLSULFONYL)PHENYL)METHYLENE)DIHYDRO-2(3H)-FURANONE, (3Z)-920350682ZIACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
CARTHAMUS TINCTORIUS FLOWER OILSDQ136WIM5IACT

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
798703c3-57e4-2723-e053-2a91aa0a4f58798703ab-16ba-6da3-e053-2991aa0a46882018-10-31WarningsExact identifier
spl id: 798703c3-57e4-2723-e053-2a91aa0a4f58
spl set id: 798703ab-16ba-6da3-e053-2991aa0a4688

Reported adverse events (FAERS/openFDA)#

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