MedPath

Owell Naturals Draw Salve with Aloe

Owell Naturals Draw Salve with Aloe

Approved
Approval ID

1aa2e783-4d79-389d-e063-6394a90a1b3c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 12, 2025

Manufacturers
FDA

Owell Naturals Brand LLC

DUNS: 122280778

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Camphora HPUS

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83570-535
Product Classification
G
Generic Name
Camphora HPUS
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 12, 2025
FDA Product Classification

INGREDIENTS (15)

WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
ARNICA MONTANA FLOWERActive
Quantity: 0.283 g in 28.3 g
Code: OZ0E5Y15PZ
Classification: ACTIB
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
WHITE PINE OILInactive
Code: HA5CX6676U
Classification: IACT
EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT
OLIVE OILInactive
Code: 6UYK2W1W1E
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
FRANKINCENSE OILInactive
Code: 67ZYA5T02K
Classification: IACT
COMFREY LEAFInactive
Code: DG4F8T839X
Classification: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022Y
Classification: IACT
CAMPHOR (NATURAL)Inactive
Code: N20HL7Q941
Classification: IACT
STELLARIA MEDIAInactive
Code: 2H03479QVR
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/21/2024

Inside w Aloe 1.0 oz.label art FOR OWELL NATURALS DRAW SALVE with CAMPHORA AND ALOE

Draw Salve w Aloe 1.0 oz.

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/2/2024

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 - PURPOSE SECTION

LOINC: 55105-1Updated: 4/2/2024

Arnica Montana HPUS 30C 1 percentPurpose Anti-inflammatory

Silicea HPUS 30C 0.10 percentPurpose Minor skin eruptions

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/2/2024

Camphora, HPUS 3X

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 4/2/2024

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

LOINC: 50569-3Updated: 4/2/2024

Ask a doctor before use if you have

redness over the affected area

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 4/2/2024

When using this product

avoid contact with eyes or other sensitive areas

do not bandage tightly

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 4/2/2024

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

LOINC: 50565-1Updated: 4/2/2024

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

LOINC: 34068-7Updated: 4/2/2024

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

LOINC: 60561-8Updated: 4/2/2024

store at room temperature

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/2/2024

Manufactured forOwell Naturals

Southfields, NY 10975

owellnaturals.com

Questions?

Customer Care: www.owellnaturals.com

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/2/2024

Inactive Ingredients

Aloe barbadensis (Aloe Vera), 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

WARNINGS SECTION

LOINC: 34071-1Updated: 4/2/2024

**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

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