Active Ingredients
Camphor 3.1%
Menthol 5.3%
Dragon Pain Relieving Balm
FDA Label NDC 83552-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Americanna Wellness, Inc. for the product Dragon Pain Relieving Balm (NDC 83552-113). 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 ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Camphor 3.1%.................Topical Analgesic
Menthol 5.3%...................Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only
Otc - Do Not Use
Do not use
- on wounds or damaged skin
Otc - When Using
When using this product
- avoid contact with the eyes
- do not bandage tightly
- avoid contact with the eyes
- do not bandage tightly
When using this product
Otc - Stop Use
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
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: do not use, consult a doctor.
Other Information
- store in a cool, dry place away from light
Inactive Ingredients
almond oil, beeswax, cajaput oil, cassia oil, clove oil, cocoa butter, coconut oil, grapeseed oil, hemp extract, hempseed oil, peppermint
Questions?
888.444.2702 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com
Package Label.Principal Display Panel
REGULAR STRENGTH
DRAGON
PAIN RELIEVING BALM
FULL SPECTRUM
Menthol 5.3%
Camphor 3.1%
500mg CBD
30mg CBN
30mg CBG
<.3% THC
NET WT. 3.4oz (96.4g)
* Please review the disclaimer below.
