OWELL NATURALS DRAW SALVE, ARNICA, SILICEA- arnica montana hpus, silicea hpus salve

Owell Naturals Draw Salve, Arnica, Silicea by

Drug Labeling and Warnings

Owell Naturals Draw Salve, Arnica, Silicea by is a Homeopathic medication manufactured, distributed, or labeled by Owell Naturals Brand LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Arnica Montana, HPUS

Silicea, HPUS

INDICATIONS & 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

DO NOT USE

Do not Use

on wounds or damaged skin

with a heating pad

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

ASK DOCTOR

Ask a doctor before use if you have

redness over the affected area

WHEN USING

When using this product

avoid contact with eyes or other sensitive areas

do not bandage tightly

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental ingestion.

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

DOSAGE & 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

OTHER SAFETY INFORMATION

store at room temperature

QUESTIONS

Manufactured for Owell Naturals

Southfields, NY 10975

owellnaturals.com

Questions?

Customer Care: www.owellnaturals.com

INACTIVE INGREDIENT

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

PURPOSE

Arnica Montana HPUS 30C 1 percent Purpose Anti-inflammatory

Silicea HPUS 30C 0.10 percent Purpose Minor skin eruptions

WARNINGS

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

PRINCIPAL DISPLAY PANEL

label art FOR OWELL NATURALS DRAW SALVE

Arnica 2 Oz YELLOW COMPLETE LABEL

INGREDIENTS AND APPEARANCE

OWELL NATURALS DRAW SALVE, ARNICA, SILICEA 
arnica montana hpus, silicea hpus salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83570-468
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	0.566 g  in 56.6 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	0.566 g  in 56.6 g

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX (UNII: 7G1J5DA97F)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
WHITE PINE OIL (UNII: HA5CX6676U)
EUCALYPTUS OIL (UNII: 2R04ONI662)
OLIVE OIL (UNII: 6UYK2W1W1E)
CASTOR OIL (UNII: D5340Y2I9G)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
COMFREY LEAF (UNII: DG4F8T839X)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83570-468-02	56.6 g in 1 JAR; Type 0: Not a Combination Product	07/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/05/2024

Labeler - Owell Naturals Brand LLC (122280778)