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Dragon pain relieving balm - Medication Information

Product NDC Code 83552-108
Drug Name

Dragon pain relieving balm

Type Brand
Active Ingredients
Camphor (synthetic) 3.1 g/100g
Menthol 5.3 g/100g
Route TOPICAL
Dosage Form SALVE
Application Number part348
Labeler Name Americanna Wellness, Inc.
Packages
Package NDC Code Description
83552-108-00 1 container in 1 carton (83552-108-00) / 96.4 g in 1 container
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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 YELLOW WAX CAJUPUT OIL GRAPE SEED OIL CANNABIS SATIVA SEED OIL COCONUT OIL PEPPERMINT CHINESE CINNAMON OIL HEMP COCOA BUTTER CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) ALMOND OIL 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.
XTRA STRENGTH DRAGON Pain Relieving Balm Broad Spectrum Menthol 5.3% | Camphor 3.1% 1000mg CBD 75mg CBN 75mg CBG 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 feeding
If 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