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| Product NDC Code | 83552-105 | ||||
|---|---|---|---|---|---|
| Drug Name | Dragon pain relieving balm |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SALVE | ||||
| Application Number | part348 | ||||
| Labeler Name | Americanna Wellness, 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 ingredients Camphor 3.1% Menthol 5.3%
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: do not use, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients almond oil, beeswax, cajaput oil, cassia oil, clove oil, cocoa butter, coconut oil, grapeseed oil, hemp extract, hempseed oil, peppermint
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 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 3.1%.................Topical Analgesic Menthol 5.3%..................Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Dragon Pain Relieving Balm Camphor, Menthol MENTHOL MENTHOL CHINESE CINNAMON OIL GRAPE SEED OIL CAJUPUT OIL ALMOND OIL CLOVE OIL COCONUT OIL PEPPERMINT YELLOW WAX COCOA BUTTER HEMP CANNABIS SATIVA SEED OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC)
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.Regular Strength DRAGON Pain Relieving Balm Isolate Menthol 5.3% | Camphor 3.1% 500mg CBD Net Wt 3.4oz (100mL) 1 2 3
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on wounds or damaged skin
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? 888.442.2707 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com
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 symptoms persist for more than 7 days or clear up and occur again within a few days condition worsens irritation occurs
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 the eyes 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 Do not use on wounds or damaged skin When using this product avoid contact with the eyes do not bandage tightly Stop use and ask doctor if symptoms persist for more than 7 days or clear up and occur again within a few days condition worsens irritation occurs 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