FDA.reportPublic FDA data

Phoenix Balm

Manufacturer
Amazonian Naturals, Inc. | Access Trading, SAC
Effective date
2011-11-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:14

Label at a glance#

ProductPhoenix Balm
Active ingredientCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE
Label structure12 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertions, arthritis, strains and sprains.

Dosage and administration

Rub well on the affected area.  Repeat 2 or 3 times daily. For children 2 - 12 years, consult a doctor before use.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 5%.................................... Topical Analgesic
Menthol 5% ..................................... Topical Analgesic
Methyl Salicylate 5%........................ Topical Analgesic

Purposes

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with over-exertions, arthritis, strains and sprains.

WARNINGS SECTION

Warnings    For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes and mucous membranes.
  • Do not apply to open wounds or damaged skin.
  • Do not bandage or use heating pad.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition Worsens.
  • Severe skin irritation occurs.
  • Pain persists for more than seven days.
  • Pain clears up and then recurs a few days later.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a health care 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 Poisen Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rub well on the affected area.  Repeat 2 or 3 times daily.
  • For children 2 - 12 years, consult a doctor before use.

Other Information

OTC - DO NOT USE SECTION

This product may cause allergic reaction in some people.  Test on small area before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Pine needle oil, Cats Claw and Paraffin Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phoenix Balm Box FrontPhoenix Balm Box FrontPhoenix Balm Box BackPhoenix Balm Box Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1232398camphor 5 % / menthol 5 % / methyl salicylate 5 % Topical OintmentPSN1
1232398camphor 0.05 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.05 MG/MG Topical OintmentSCD1
1232398camphor 5 % / menthol 5 % / methyl salicylate 5 % Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24438-001-022019-11-13C16284748780-197449f38-c65c-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24438-001-01Phoenix Balm19 g in 1 CONTAINEROINTMENT191
24438-001-02Phoenix Balm1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24438-001PHOENIX BALM (PAIN RELIEF RUB) OINTMENT [AMAZONIAN NATURALS, INC.]1Legacy NDC, 2 package rows20111201_1ee482e2-155b-4f82-ab90-0457911806a8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9411
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9411
MENTHOLACTIVE MOIETYL7T10EIP3A1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022Y1
CAT'S CLAWINACTIVE INGREDIENT9060PRM18Q1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
PINE NEEDLE OIL (PINUS SYLVESTRIS)INACTIVE INGREDIENT5EXL5H740Y1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24438-00124438-001-01, 24438-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
CAT'S CLAW9060PRM18QIACT
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 19 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PINE NEEDLE OIL (PINUS SYLVESTRIS)PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YLOTION / TOPICAL0.25 %w/wExact identifier — unii candidate
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates

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
fab49a9f-9c0f-4a00-81cf-c9bbd5ef08261ee482e2-155b-4f82-ab90-0457911806a82011-11-29WarningsExact identifier
spl id: fab49a9f-9c0f-4a00-81cf-c9bbd5ef0826
spl set id: 1ee482e2-155b-4f82-ab90-0457911806a8

Reported adverse events (FAERS/openFDA)#

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