Otc - Active Ingredient
CAMPHORA [HPUS]
Owell Naturals Draw Salve With Camphor Salve
FDA Label NDC 83570-491
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Owell Naturals Brand Llc for the product Owell Naturals Draw Salve With Camphor (NDC 83570-491). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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
Otc - Ask Doctor
Ask a doctor before use if you have
redness over the affected area
Otc - When Using
When using this product
avoid contact with eyes or other sensitive areas
do not bandage tightly
Otc - 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
Otc - 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
Otc - Questions
Questions?
Customer Care: www.owellnaturals.com
Inactive Ingredient
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
External Analgesic
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
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
Stop use and ask a doctor if
Recent Major Changes
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
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