FDA.reportPublic FDA data

Dragon Pain Relieving Balm

Manufacturer
Americanna Wellness, Inc.
Effective date
2023-07-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:32

Label at a glance#

ProductDragon Pain Relieving Balm
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 3.1%

Menthol 5.3%

Purpose

OTC - PURPOSE SECTION

Camphor 3.1%.................Topical Analgesic

Menthol 5.3%..................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 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

almond oil, beeswax, cajaput oil, cassia oil, clove oil, cocoa butter, coconut oil, grapeseed oil, hemp extract, hempseed oil, peppermint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XTRA STRENGTH
DRAGON Pain Relieving Balm

Isolate

Menthol 5.3% | Camphor 3.1%

1000mg CBD

Net Wt 3.4oz (100mL)

11

22

33

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83552-107-002025-01-30C16284748780-12cef2736-94bf-d83d-e063-dadaa90ab31fXtra Strength Isolate 3.4 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83552-107-00Dragon Pain Relieving Balm96.4 g in 1 CONTAINERSALVE96.41
83552-107-00Dragon Pain Relieving Balm1 in 1 CARTONSALVE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83552-107DRAGON PAIN RELIEVING BALM (CAMPHOR, MENTHOL) SALVE [AMERICANNA WELLNESS, INC.]12 package rows20230712_0037842e-2fcc-e9c3-e063-6294a90aec5e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83552-10783552-107-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEMPTD1MUT01Q7IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
ALMOND OIL66YXD4DKO9IACT
YELLOW WAX2ZA36H0S2VIACT
CHINESE CINNAMON OILA4WO0626T5IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CLOVE OIL578389D6D0IACT
PEPPERMINTV95R5KMY2BIACT
COCONUT OILQ9L0O73W7LIACT
MENTHOLL7T10EIP3AACTIB
CAJUPUT OILJ3TO6BUQ37IACT
COCOA BUTTER512OYT1CRRIACT
GRAPE SEED OIL930MLC8XGGIACT

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
0037842e-2fcd-e9c3-e063-6294a90aec5e0037842e-2fcc-e9c3-e063-6294a90aec5e2023-07-11WarningsExact identifier
spl id: 0037842e-2fcd-e9c3-e063-6294a90aec5e
spl set id: 0037842e-2fcc-e9c3-e063-6294a90aec5e

Reported adverse events (FAERS/openFDA)#

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