Active Ingredient
Camphor 3.3%
Proflexa
FDA Label NDC 83011-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sinoveda Canada Inc for the product Proflexa (NDC 83011-001). 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 active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Camphor 3.3%......................Topical Analgesic
Uses
For the temporary relief of the minor aches and pains of muscles and joints associated with:
- Simple Backache
- Arthritis
- Strains
- Bruises
- Sprains
Warnings
For external use only
Otc - When Using
When using this product
- Avoid contact with eyes
- Do not apply to wounds or damaged skin
- Do not bandage tightly
Otc - Stop Use
Stop use and ask doctor if
- Condition worsens
- Irritation occurs
- Symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: Consult a doctor
Other Information
Store in a cool, dry place away from light
Inactive Ingredients
Angelica Polymorpha Sinensis Root Extract, Boswellia Sacra (Frankincense) Gum/Resin Extract, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Flower Extract, Cetearyl Olivate, Citrus Paradisi (Grapefruit) Seed Extract, Commiphora Myrrha Resin Extract, Eugenia Caryophyllus (Clove) Flower Oil, Glycerin, Glyceryl Stearate Citrate, Isopropyl Palmitate, Ligusticum Chuanxiong Root Extract, Sodium Benzoate, Sodium Hyaluronate, Stearyl Alcohol, Vitis Vinifera (Grape) Seed Oil, Xanthan Gum
Questions Or Comments?
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Package Label.Principal Display Panel
Proflexa
Botanical Pain Relief Cream for Muscles and Joints
Camphor 3.3%
NDC #: 83011-001-01
Radiate Freedom
Net Wt 1.76 oz (50g)
* Please review the disclaimer below.
