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

Key Label Information#

Active Ingredients And Purpose

Active ingredients

Camphor 3.1% Menthol 5.3%

Purpose

Camphor 3.1%.................Topical Analgesic Menthol 5.3%..................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?

888.442.2707 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com

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)

Label Images#

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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#

NDC Codes#

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

Ingredients#

Complete SPL Sections#

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

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

888.442.2707 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 Isolate Menthol 5.3% | Camphor 3.1% 1000mg CBD Net Wt 3.4oz (100mL)

Source Document#

Source XML