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| Product NDC Code | 83011-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Proflexa |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 2619330, 2619335 |
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| Application Number | part348 | ||||
| Labeler Name | Sinoveda Canada Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Camphor 3.3%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of the minor aches and pains of muscles and joints associated with: Simple Backache Arthritis Strains Bruises Sprains
Purpose
Information about the drug product’s indications for use.Purpose Camphor 3.3%......................Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Proflexa Camphor SAFFLOWER CETEARYL OLIVATE CITRUS PARADISI SEED MYRRH GLYCERIN GLYCERYL STEARATE CITRATE ISOPROPYL PALMITATE LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT SODIUM BENZOATE HYALURONATE SODIUM STEARYL ALCOHOL GRAPE SEED OIL XANTHAN GUM ANGELICA POLYMORPHA ROOT BOSWELLIA SACRA WHOLE SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES CAMPHOR (NATURAL) CAMPHOR (NATURAL) CLOVE OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Proflexa Botanical Pain Relief Cream for Muscles and Joints Camphor 3.3% NDC #: 83011-001-01 Radiate Freedom Net Wt 1.76 oz (50g) 2 3 1
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-780-466-0086 Mon-Fri 9am-5pm MST 954-414-0380
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product Avoid contact with eyes Do not apply to wounds or damaged skin Do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store in a cool, dry place away from light
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only When using this product Avoid contact with eyes Do not apply to wounds or damaged skin Do not bandage tightly 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 If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API