FDA.reportPublic FDA data

Dragon Pain Relieving Balm

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 01:17:41

Key Label Information#

Active Ingredients And Purpose

Active ingredients

Camphor 10% Menthol 11%

Purpose

Camphor 10%.................Topical Analgesic Menthol 11%...................Topical Analgesic

Uses

Uses

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

Warnings

Warnings

For external use only

Directions And Dosage

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 Label Information

Other information

store in a cool, dry place away from light

Inactive ingredients

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

Questions?

888.444.2702 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XTRA STRENGTH DRAGON PAIN RELIEVING BALM BROAD SPECTRUM Menthol 11% Camphor 10% 1000mg CBD 75mg CBN 75mg CBG NET WT. 3.4oz (96.4g)

Label Images#

83552-115-00 Dragon 3.4 Rollup Xtra Broad Spectrum CARTON
83552-115-00 Dragon 3.4 Rollup Xtra Broad Spectrum CARTON
83552-115-00 Dragon 3.4 Rollup Xtra Broad Spectrum INNER
83552-115-00 Dragon 3.4 Rollup Xtra Broad Spectrum INNER

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83552-115-002025-11-24C16284748780-12cef2736-a674-d83d-e063-dadaa90ab31fDragon Pain Relieving Balm 3.4oz (XS BS)
83552-115-002025-01-30C16284748780-12cef2736-a674-d83d-e063-dadaa90ab31fDragon Pain Relieving Balm 3.4oz (XS BS)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83552-115-00Dragon Pain Relieving Balm1 in 1 CARTONSALVE12
83552-115-00Dragon Pain Relieving Balm96.4 g in 1 CONTAINERSALVE96.42

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83552-11583552-115-00

Ingredients#

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

Complete SPL Sections#

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

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

Questions?

OTC - QUESTIONS SECTION

888.444.2702 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XTRA STRENGTH DRAGON PAIN RELIEVING BALM BROAD SPECTRUM Menthol 11% Camphor 10% 1000mg CBD 75mg CBN 75mg CBG NET WT. 3.4oz (96.4g)

Source Document#

Source XML