FDA.reportPublic FDA data

Owell Naturals Draw Salve with Camphor

Manufacturer
Owell Naturals Brand LLC
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:31:45

Label at a glance#

ProductOwell Naturals Draw Salve with Camphor
Active ingredientCAMPHOR (NATURAL)
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

CAMPHORA [HPUS]

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains associated with

Boils

Cysts

Splinters

Thorns

Ingrown Hairs

Pain

Itch & Irritation Relief

Dry Skin

Insect Bites

Bee Sting

Cuts

Poison Ivy/Oak

Burns

OTC - DO NOT USE SECTION

Do not Use

on wounds or damaged skin

with a heating pad

on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

redness over the affected area

OTC - WHEN USING SECTION

When using this product

avoid contact with eyes or other sensitive areas

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

symptoms clear up and occur again within a few days

excessive skin irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental ingestion.

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

DOSAGE & ADMINISTRATION SECTION

Directions

Use only as directed

adults and children 12 years of age and older, apply to affected area

children under 12 years of age, ask a doctor

OTHER SAFETY INFORMATION

store at room temperature

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Arnica Montana Flower Extract, Beeswax, Boswellia carterii (Frankincense) Oil, Calendula Officinalis (Marigold) Extract, Eucalyptus Oil,

Lavandula angustifolia (Lavender) Oil, Melaleuca alternifolia (Tea Tree) Oil, Methyl Salicylate, Olea Europaea (Olive) Fruit Oil,

Pinus sylvestris (Pine) Leaf Oil, Ricinus communis (Castor) Seed Oil, Silica, Symphytum Officinale (Comfrey) Leaf Extract

OTC - PURPOSE SECTION

External Analgesic

WARNINGS SECTION

Allergy Alert: If prone to allergic reaction from aspirin or salicylate, consult your doctor before using.

Do Not Use:

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Stop use and ask a doctor if

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

RECENT MAJOR CHANGES SECTION

Uses No Major Changes. This is a Second product for this client.

Doses and Administration. No major changes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LABEL ART

OWELL DRAW SALVE W CAMPHORA AND NEW TEXT

1.0 Camphora w NEW TEXT1.0 Camphora w NEW TEXT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83570-491-01Owell Naturals Draw Salve with Camphor28.3 g in 1 JARSALVE28.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83570-491OWELL NATURALS DRAW SALVE WITH CAMPHOR (CAMPHOR) SALVE [OWELL NATURALS BRAND LLC]3Current NDC, 1 package rows20250201_1c5cc9c6-a77a-75d8-e063-6294a90ad6c0.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83570-49183570-491-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WHITE WAX7G1J5DA97FIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
WHITE PINE OILHA5CX6676UIACT
EUCALYPTUS OIL2R04ONI662IACT
OLIVE OIL6UYK2W1W1EIACT
CASTOR OILD5340Y2I9GIACT
FRANKINCENSE OIL67ZYA5T02KIACT
METHYL SALICYLATELAV5U5022YIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
COMFREY LEAFDG4F8T839XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
Owell Naturals Draw Salve with CamphorCAMPHOROwell Naturals Brand LLC1c5cc9c6-a77a-75d8-e063-6294a90ad6c02024-10-14WarningsExact identifier
ndc (package): 83570-491-01
ndc (product): 83570-491
ndc11 (package): 83570049101
spl id: 2cee6ab6-bb3c-2cfd-e063-6394a90a9ea6
spl set id: 1c5cc9c6-a77a-75d8-e063-6294a90ad6c0

Reported adverse events (FAERS/openFDA)#

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