FDA.reportPublic FDA data

Dragon Pain Relieving Lotion 16.9oz

Manufacturer
AMERICANNA WELLNESS, INC.
Effective date
2025-11-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:17:59

Label at a glance#

ProductDragon Pain Relieving
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Dosage and administration

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.

Storage and handling

store in a cool, dry place away from light

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 10%

Menthol 11%

Purpose

OTC - PURPOSE SECTION

Camphor 10%................Topical Analgesic

Menthol 11%..................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes
  • do not bandage tightly

OTC - STOP USE SECTION

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 SECTION

If pregnant or breastfeeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • store in a cool, dry place away from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

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)

11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850052779023GTIN-13: 0850052779023
EAN-13: 0850052779023
GTIN-12: 850052779023
UPC-A: 850052779023
GTIN storage (14 digits): 00850052779023		83552-120-00 Dragon 16.9 Lotion .jpg
QR code linkQR Codeamericannawellness.com/lab-results/83552-120-00 Dragon 16.9 Lotion .jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83552-120-002025-11-24C16284748780-12cef2736-916f-d83d-e063-dadaa90ab31fDragon Pain Relieving Lotion 16.9oz
83552-120-002025-01-30C16284748780-12cef2736-916f-d83d-e063-dadaa90ab31fDragon Pain Relieving Lotion 16.9oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83552-120-00Dragon Pain Relieving479 g in 1 BOTTLE, PUMPLOTION4792

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83552-12083552-120-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAJUPUT OILJ3TO6BUQ37IACT
STEARYL ALCOHOL2KR89I4H1YIACT
PEG-100 STEARATEYD01N1999RIACT
PEPPERMINT OILAV092KU4JHIACT
SUNFLOWER SEEDR9N3379M4ZIACT
SHEA BUTTERK49155WL9YIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
CLOVE OIL578389D6D0IACT
SODIUM HYDROXIDE55X04QC32IIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CHINESE CINNAMON OILA4WO0626T5IACT
POLYSORBATE 207T1F30V5YHIACT
PETROLATUM4T6H12BN9UIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
STEARIC ACID4ELV7Z65APIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
OLIVE OIL6UYK2W1W1EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d1059cc-1b0b-4e7b-e063-6294a90a56ea2025-11-24WarningsExact identifier
ndc (package): 83552-120-00
ndc (product): 83552-120
ndc11 (package): 83552012000
spl id: 445f4d50-effc-7f7b-e063-6294a90a679a
spl set id: 0d1059cc-1b0b-4e7b-e063-6294a90a56ea

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.