FDA.reportPublic FDA data

Dragon Pain Relieving

Manufacturer
Americanna Wellness, Inc.
Effective date
2024-04-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:57

Label at a glance#

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

Indications and uses

For the temporary relief of minor achse 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 11%

Menthol 13%

Purpose

OTC - PURPOSE SECTION

Camphor 11%.....................Topical Analgesic

Menthol 13%.......................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor achse 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 the eyes
  • do not bandage tightly

OTC - STOP USE SECTION

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 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 Seed Oil, Peppermint Oil, Polysorbate 20.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Silver Strength

Dragon Pain Relieving Lotion

Menthol 13% | Camphor 11%

Net Wt 3.4oz (96.4g)

11

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83552-129-00Dragon Pain Relieving1 in 1 CARTONLOTION12
83552-129-00Dragon Pain Relieving96.4 g in 1 TUBELOTION96.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83552-129DRAGON PAIN RELIEVING (CAMPHOR, MENTHOL) LOTION [AMERICANNA WELLNESS, INC.]22 package rows20240412_155216ae-46e8-4774-e063-6394a90a4704.zip

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
83552-12983552-129-00

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
PHENOXYETHANOLHIE492ZZ3TIACT
SUNFLOWER OIL3W1JG795YIIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
STEARYL ALCOHOL2KR89I4H1YIACT
SHEA BUTTERK49155WL9YIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM HYDROXIDE55X04QC32IIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
STEARIC ACID4ELV7Z65APIACT
ALOEV5VD430YW9IACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
TOCOPHEROLR0ZB2556P8IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PETROLATUM4T6H12BN9UIACT
CAJUPUT OILJ3TO6BUQ37IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CLOVE OIL578389D6D0IACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
MENTHOLL7T10EIP3AACTIB
PEPPERMINT OILAV092KU4JHIACT
CHINESE CINNAMON OILA4WO0626T5IACT
OLIVE OIL6UYK2W1W1EIACT
CHAMOMILEFGL3685T2XIACT

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
15c797df-749e-0b0a-e063-6394a90a60c9155216ae-46e8-4774-e063-6394a90a47042024-04-10WarningsExact identifier
spl id: 15c797df-749e-0b0a-e063-6394a90a60c9
spl set id: 155216ae-46e8-4774-e063-6394a90a4704

Reported adverse events (FAERS/openFDA)#

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