Active Ingredients
Camphor 10%
Menthol 11%
Dragon Pain Relieving Lotion
FDA Label NDC 83552-120
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 (NDC 83552-120). 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 10%................Topical Analgesic
Menthol 11%..................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 eyes
- do not bandage tightly
Otc - Stop Use
Stop use and ask doctor if
- symptoms perists 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
Lotion Base (Water, Sunflower Seed Oil, Isopropyl Palmitate, Stearic Acid, Stearyl Alcohol, Aloe Leaf Juice, Shea Butter, Olea Europaea Olive Fruit Oil, Titanium Dioxide, Tocopheryl Acetate, Chamomilla Recutita Matricaria Flower Extract, Sodium Hydroxide, Glyceryl Stearate, Phenoxyethanol, Petrolatum, PEG-100 Stearate, Carbomer, Glycerin, Ethylhexylglycerin, Tocopherol) Cajeput Oil, Cassia Oil, Clove Oil, Hemp Extracted Oil, Peppermint Oil, Polysorbate 20
Questions?
888.442-2702 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com
Package Label.Principal Display Panel
AMERICANNA WELLNESS
XTRA STRENGTH
DRAGON PAIN RELIEVING LOTION
BROAD SPECTRUM
Menthol 11%
Camphor 10%
5000mg CBD
375mg CBN
375mg CBG
NET WT 16.9oz (479g)
* Please review the disclaimer below.
