FDA.reportPublic FDA data

Extra Strength Pain Relief Cream

Manufacturer
Sagely Enterprises Inc. | Verde Cosmetic Labs, LLC
Effective date
2021-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:00

Label at a glance#

ProductExtra Strength Pain Relief Cream
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

temporarily relieves the minor aches and pains of muscles and joints associated with: strains bruises simple backache arthritis sprains

Dosage and administration

Use only as directed Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Menthol 10%..............Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • strains
  • bruises
  • simple backache
  • arthritis
  • sprains

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged, broken, or irritated skin
  • with a heating pad

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days or clear up and occur again wtihin a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, 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

  • Use only as directed
  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 12 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propanediol, Cetyl Alcohol, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Glucoside, Cetearyl Alcohol, Diheptyl Succinate, Xanthan Gum, Boswellia Serrata Resin Extract, Safflower (Carthamus Tinctorius) Seed Oil, Hemp (Cannabis Sativa) Seed Oil, Marula (Sclerocarya Birrea) Seed Oil, Argan (Argania Spinosa) Kernel Oil, Tocopheryl Acetate, Camphor, Peppermint (Mentha Piperita) Oil, Glyceryl Caprylate, Caprylhydroxamic Acid, Sodium Hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sagely Naturals

Extra Strength Pain Relief Cream

Instant Cooling

With 10% Menthol

95% Natural Ingredients

4 FL OZ / 118 ML

11

22

11

22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253020menthol 10 % Topical CreamPSN2
253020menthol 100 MG/ML Topical CreamSCD2
253020menthol 10 % Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82075-415-002024-01-30C16284748780-11030e365-426d-111a-e063-dadaa90a10e2Extra Strength Pain Relief Cream
82075-415-152024-01-30C16284748780-11030e365-426d-111a-e063-dadaa90a10e2Extra Strength Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82075-415-00Extra Strength Pain Relief Cream1 in 1 CARTONCREAM12
82075-415-00Extra Strength Pain Relief Cream88 g in 1 TUBECREAM882
82075-415-15Extra Strength Pain Relief Cream118 g in 1 BOTTLE, PUMPCREAM1182
82075-415-15Extra Strength Pain Relief Cream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82075-415EXTRA STRENGTH PAIN RELIEF CREAM (MENTHOL) CREAM [SAGELY ENTERPRISES INC.]2Legacy NDC, 4 package rows20211121_c6264c23-5803-324c-e053-2a95a90a9719.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82075-41582075-415-15, 82075-415-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
SAFFLOWER OIL65UEH262ISIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
PEPPERMINT OILAV092KU4JHIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
PROPANEDIOL5965N8W85TIACT
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BOSWELLIA SERRATA RESIN OIL5T1XCE6K8KIACT
SCLEROCARYA BIRREA SEED OILWDO4TLS35FIACT
ARGAN OIL4V59G5UW9XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL ALCOHOL936JST6JCNIACT
DIHEPTYL SUCCINATE057N7SS26YIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM HYDROXIDE55X04QC32IIACT
XANTHAN GUMTTV12P4NEEIACT

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
d12a2843-3621-0449-e053-2995a90af52ac6264c23-5803-324c-e053-2a95a90a97192021-11-19WarningsExact identifier
spl id: d12a2843-3621-0449-e053-2995a90af52a
spl set id: c6264c23-5803-324c-e053-2a95a90a9719

Reported adverse events (FAERS/openFDA)#

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