FDA.reportPublic FDA data

Dragon Pain Relieving Balm

Manufacturer
AMERICANNA WELLNESS, INC.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:05:21

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 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 the eyes
  • do not bandage tightly

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 11%

Camphor 10%

1000mg CBD

NET WT. 3.4oz (96.4g)

11

22

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83552-114-002025-01-30C16284748780-12cef2736-6016-d83d-e063-dadaa90ab31fDragon Pain Relieving Balm 3.4oz (XS I)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83552-114-00Dragon Pain Relieving Balm96.4 g in 1 CONTAINERSALVE96.41
83552-114-00Dragon Pain Relieving Balm1 in 1 CARTONSALVE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83552-114DRAGON PAIN RELIEVING BALM (CAMPHOR, MENTHOL) SALVE [AMERICANNA WELLNESS, INC.]12 package rows20231222_0d129641-eaee-c3ee-e063-6394a90aa58f.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
83552-11483552-114-00

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
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
CHINESE CINNAMON OILA4WO0626T5IACT
CLOVE OIL578389D6D0IACT
GRAPE SEED OIL930MLC8XGGIACT
CAJUPUT OILJ3TO6BUQ37IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
PEPPERMINT OILAV092KU4JHIACT
MENTHOLL7T10EIP3AACTIB
ALMOND OIL66YXD4DKO9IACT
YELLOW WAX2ZA36H0S2VIACT
COCOA BUTTER512OYT1CRRIACT
COCONUT OILQ9L0O73W7LIACT
HEMPTD1MUT01Q7IACT

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
0d12a4f5-e78a-cfa1-e063-6294a90aa6e60d129641-eaee-c3ee-e063-6394a90aa58f2023-12-21WarningsExact identifier
spl id: 0d12a4f5-e78a-cfa1-e063-6294a90aa6e6
spl set id: 0d129641-eaee-c3ee-e063-6394a90aa58f