FDA.reportPublic FDA data

Dermaline Camphor Ointment

Manufacturer
Dermaline USA Corp | World Perfumes Inc
Effective date
2023-02-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:06

Label at a glance#

ProductTopical Analgesic
Active ingredientCAMPHOR (SYNTHETIC)
Label structure13 sections

Dosage and administration

Adults and children 16 years of age and older. Wash the affected area with mild soap and warm water and rinse thorougly. Apply to affected area not more than 3 to 4 times a day.

Storage and handling

Store between 15-30C (59-86F) Do not expose to excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

LabelLabelCamphor 10%. Purpose: Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

WARNINGS SECTION

For external use only. Flammable. Avoid contact with the eyes. Do not bandage tightly or apply to wounds or damaged skin.

Do not use

OTC - DO NOT USE SECTION

On children under 16 years of age except on the advice of a physician.

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, or if symtpoms 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 16 years of age and older. Wash the affected area with mild soap and warm water and rinse thorougly. Apply to affected area not more than 3 to 4 times a day.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Do not expose to excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

cyclomethicone, white petrolatum

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel70g NDC: 82165-103-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
418604camphor 10 % Topical OintmentPSN2
418604camphor 0.1 MG/MG Topical OintmentSCD2
418604camphor 10 % Topical OintmentSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82165-103-022025-01-30C16284748780-1f386c64a-01d4-0266-e053-dadaa90a7c1aDermaline Camphor Ointment
82165-103-022023-02-14C16284748780-1f386c64a-01d4-0266-e053-dadaa90a7c1aDermaline Camphor Ointment
82165-103-022023-01-30C16284748780-1f386c64a-01d4-0266-e053-dadaa90a7c1aDermaline Camphor Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82165-103-02Topical Analgesic70 g in 1 JAROINTMENT702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82165-103TOPICAL ANALGESIC (DERMALINE CAMPHOR) OINTMENT [DERMALINE USA CORP]2Legacy NDC, 1 package rows20230215_cca1e65e-4bd2-58c2-e053-2a95a90aa82d.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82165-10382165-103-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WHITE PETROLATUMB6E5W8RQJ4IACT
CYCLOMETHICONENMQ347994ZIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

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
f49c1fe8-7774-58c3-e053-2a95a90a00f9cca1e65e-4bd2-58c2-e053-2a95a90aa82d2023-02-13WarningsExact identifier
spl id: f49c1fe8-7774-58c3-e053-2a95a90a00f9
spl set id: cca1e65e-4bd2-58c2-e053-2a95a90aa82d

Reported adverse events (FAERS/openFDA)#

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