Owell Naturals Draw Salve

Owell Naturals Draw Salve
SPL v1
SPL
SPL Set ID 1b2f505c-d850-e5ca-e063-6394a90a486b
Route
TOPICAL
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Flower (0.283 g) Silicon Dioxide (0.0283 g)
Inactive Ingredients
White Wax Calendula Officinalis Flower Lavender Oil Tea Tree Oil White Pine Oil Eucalyptus Oil Olive Oil Castor Oil Frankincense Oil Comfrey Leaf Methyl Salicylate Camphor (natural)

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-06-25

Description

Arnica Montana, HPUS Silicea, HPUS


Medication Information

Warnings and Precautions

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

Indications and Usage

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

Dosage and Administration

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

Description

Arnica Montana, HPUS Silicea, HPUS

Section 50565-1

Keep out of reach of children to avoid accidental ingestion.

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

Section 50566-9

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

Section 50567-7

When using this product

avoid contact with eyes or other sensitive areas

do not bandage tightly

Section 50569-3

Ask a doctor before use if you have

redness over the affected area

Section 50570-1

Do not Use

on wounds or damaged skin

with a heating pad

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

Section 51727-6

Inactive Ingredients

Beeswax, Boswellia carterii (Frankincense) Oil, Calendula Officinalis (Marigold) Extract, Camphor USP, 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, Symphytum Officinale (Comfrey) Leaf Extract

Section 51945-4

label art FOR OWELL NATURALS DRAW SALVE

2.0 oz. Arnica and Silicea

and the inside Drug Facts

Section 53413-1

Manufactured for Owell Naturals

Southfields, NY 10975

owellnaturals.com

Questions?

Customer Care: www.owellnaturals.com

Section 55105-1

Arnica Montana HPUS 30C 1 percent Purpose Anti-inflammatory

Silicea HPUS 30C 0.10 percent Purpose Minor skin eruptions

Section 55106-9

Arnica Montana, HPUS

Silicea, HPUS

Section 60561-8

store at room temperature


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental ingestion.

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

avoid contact with eyes or other sensitive areas

do not bandage tightly

Section 50569-3 (50569-3)

Ask a doctor before use if you have

redness over the affected area

Section 50570-1 (50570-1)

Do not Use

on wounds or damaged skin

with a heating pad

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

Section 51727-6 (51727-6)

Inactive Ingredients

Beeswax, Boswellia carterii (Frankincense) Oil, Calendula Officinalis (Marigold) Extract, Camphor USP, 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, Symphytum Officinale (Comfrey) Leaf Extract

Section 51945-4 (51945-4)

label art FOR OWELL NATURALS DRAW SALVE

2.0 oz. Arnica and Silicea

and the inside Drug Facts

Section 53413-1 (53413-1)

Manufactured for Owell Naturals

Southfields, NY 10975

owellnaturals.com

Questions?

Customer Care: www.owellnaturals.com

Section 55105-1 (55105-1)

Arnica Montana HPUS 30C 1 percent Purpose Anti-inflammatory

Silicea HPUS 30C 0.10 percent Purpose Minor skin eruptions

Section 55106-9 (55106-9)

Arnica Montana, HPUS

Silicea, HPUS

Section 60561-8 (60561-8)

store at room temperature


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)