FDA.reportPublic FDA data

Apeaz Ultra

Manufacturer
Innovus Pharmaceuticals, Inc.
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:49:21

Label at a glance#

ProductApeaz Ultra
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure12 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises 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

Storage and handling

Store at 20° to 25°C (68° to 77°F) Do not purchase if outer seal is broken

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%

Menthol 7.5%

Methyl Salicylate 10%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings​

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Center immediately

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

Other information

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F)

Do not purchase if outer seal is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, cetearyl alcohol, water, FD&C Blue no 1, FD&C Yellow no 5, glucosamine sulfate, glyceryl monostearate, methyl sulfonyl methane, methylparaben, mineral oil 90, PEG-100, propylparaben, polysorbate 60, stearyl alcohol, triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2474491Apeaz Ultra 4 % / 7.5 % / 10 % Topical CreamPSN4
1998770camphor 4 % / menthol 7.5 % / methyl salicylate 10 % Topical CreamPSN4
2474491camphor 40 MG/ML / menthol 75 MG/ML / methyl salicylate 100 MG/ML Topical Cream [Apeaz]SBD4
1998770camphor 40 MG/ML / menthol 75 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD4
2474491Apeaz Ultra (camphor 4 % / menthol 7.5 % / methyl salicylate 10 % ) Topical CreamSY4
1998770camphor 4 % / menthol 7.5 % / methyl salicylate 10 % Topical CreamSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57483-101-012023-01-27C16284748780-19d75b9d0-ed3d-f424-e053-dadaa90a57ceApeaz Ultra
57483-101-012020-01-31C16284748780-19d75b9d0-ed3d-f424-e053-dadaa90a57ceApeaz Ultra

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57483-101-01Apeaz Ultra1 in 1 CARTONCREAM14
57483-101-01Apeaz Ultra56.7 g in 1 CONTAINERCREAM56.74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-101APEAZ ULTRA (CAMPHOR (SYNTHETIC), MENTHOL, AND METHYL SALICYLATE CREAM) CREAM [INNOVUS PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20241228_ec93ca9d-ef59-456f-ac08-d50936f70424.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57483-10157483-101-01

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
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
MINERAL OILT5L8T28FGPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 60CAL22UVI4MIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
33a5b424-4226-40be-b009-91eea7fa66abec93ca9d-ef59-456f-ac08-d50936f704242024-12-27WarningsExact identifier
spl id: 33a5b424-4226-40be-b009-91eea7fa66ab
spl set id: ec93ca9d-ef59-456f-ac08-d50936f70424

Reported adverse events (FAERS/openFDA)#

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