Atomic Balm

Manufacturer
The Hygenic Company, LLC
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:08

Label at a glance#

ProductAtomic Balm
Active ingredientMETHYL SALICYLATE, CAPSAICIN
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, bruises, simple backache, and arthritis. Combined with stretching and calisthenics, Atomic Balm assists in the warm-up process, especially in cool, damp weather. Do not bandage tightly.

Dosage and administration

Gently massage into painful area. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor. To apply: spread 1/8 " layer of Atomic Balm over area. Do not bandage tightly.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 12.5%

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Counterirritant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, bruises, simple backache, and arthritis. Combined with stretching and calisthenics, Atomic Balm assists in the warm-up process, especially in cool, damp weather. Do not bandage tightly.

Warnings

WARNINGS SECTION

For external use only.

Use only as directed. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Do not apply to wounds or damaged skin. Avoid contact with the eyes. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor.

Consult a doctor

OTC - ASK DOCTOR SECTION

before administering to children, including teenagers, with chicken pox or flu.

Keep this and all drugs out of the reach of children 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

to avoid accidental poisoning.

Directions

DOSAGE & ADMINISTRATION SECTION

Gently massage into painful area. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor. To apply: spread 1/8 " layer of Atomic Balm over area. Do not bandage tightly.

Other Information

SPL UNCLASSIFIED SECTION

This product will cause mild skin irritation. Discontinue use is excessive irritation of skin develops. Use with caution on sensitive skin. Store in a cool, dry place with cap closed tightly.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Paraffin Wax, Petrolatum

Questions?

OTC - QUESTIONS SECTION

(800) 345-2231

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label7Label7

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2597539Atomic Balm 0.025 % / 12.5 % Topical OintmentPSN2
1923329capsaicin 0.025 % / methyl salicylate 12.5 % Topical OintmentPSN2
2597539capsaicin 0.00025 MG/MG / methyl salicylate 0.125 MG/MG Topical Ointment [Atomic Balm]SBD2
1923329capsaicin 0.00025 MG/MG / methyl salicylate 0.125 MG/MG Topical OintmentSCD2
2597539Atomic Balm (capsaicin 0.025 % / methyl salicylate 12.5 % ) Topical OintmentSY2
1923329capsaicin 0.025 % / methyl salicylate 12.5 % Topical OintmentSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82345-856-01Atomic Balm454 g in 1 JAROINTMENT4542

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82345-856ATOMIC BALM (METHYL SALICYLATE, CAPSAICIN) OINTMENT [THE HYGENIC COMPANY, LLC]2Current NDC, Legacy NDC, 1 package rows20231106_d10028f3-ae6a-7b01-e053-2995a90a5a84.zip

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
82345-85682345-856-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
Atomic BalmMETHYL SALICYLATE, CAPSAICINThe Hygenic Company, LLCd10028f3-ae6a-7b01-e053-2995a90a5a842023-11-05WarningsExact identifier
ndc (package): 82345-856-01
ndc (product): 82345-856
ndc11 (package): 82345085601
spl id: 097358e0-ead1-c991-e063-6294a90acb81
spl set id: d10028f3-ae6a-7b01-e053-2995a90a5a84

Reported adverse events (FAERS/openFDA)#

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