Active HYDROGEN Professional gel

Manufacturer
8.0 IDEAL BALANCE D.O.O. BEOGRAD
Effective date
2019-03-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:51

Label at a glance#

ProductActive HYDROGEN Professional gel
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Reduces and stops the inflammatory process, eliminates pain, reduces swelling, speeds up recovery process after injuries, neutralizes excretion of lactic acid in the muscles

Dosage and administration

adults and children over 12 years: • apply a thin layer to the target - the sore spot • massage into painful area until thoroughly absorbed into skin • repeat the process several (4 to 5) times • wipe over with wet hand to remove any sense of tension • repeat the process minimum 3 times per days Children 12 years or younger : ask a doctor

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

  • For external use only
  • When using this product

• use only as directed

• do not bandage or use with heating pad or medicated patch

• avoid contact with eyes and mucous membranes

• do not apply to open wounds or damaged, broken or irritated skin

• a slight burning may occur upon application with disappearing effect in short period of time

Purpose 

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Reduces and stops the inflammatory process, eliminates pain, reduces swelling, speeds up
recovery process after injuries, neutralizes excretion of lactic acid in the muscles

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:
• apply a thin layer to the target - the sore spot
• massage into painful area until thoroughly absorbed into skin

• repeat the process several (4 to 5) times • wipe over with wet hand to remove any sense of tension

• repeat the process minimum 3 times per days Children 12 years or younger: ask a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If preganant or breast-feeding, ask a health professional before use.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Stop use and ask doctor if

OTC - STOP USE SECTION

• condition worsens

• redness is present

• irritation develops
• symptoms persist for more then 7 days or clear up and occur again within a few days

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.2 % 

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Ascorbic Acid, Boric Acid, Carboxy Methyl Cellulose, Magnesium Oxide, Potassium Sorbate, Glycerol.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product labelproduct label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2045038menthol 1.2 % Topical GelPSN1
2045038menthol 0.012 MG/MG Topical GelSCD1
2045038menthol 1.2 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72901-001-012021-01-29C16284748780-1ba0f9c33-4e56-a910-e053-dadaa90a0b85active HYDROGEN Professional gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72901-001-01Active HYDROGEN Professional gel100 mL in 1 TUBEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72901-001ACTIVE HYDROGEN PROFESSIONAL GEL (MENTHOL) GEL [8.0 IDEAL BALANCE D.O.O. BEOGRAD]1Legacy NDC, 1 package rows20190318_3c5f7e57-b6c7-4372-ab1e-4aa2cb8bf2f1.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72901-00172901-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
7efedc35-88e1-4374-8cb1-188b83626f973c5f7e57-b6c7-4372-ab1e-4aa2cb8bf2f12019-03-13WarningsExact identifier
spl id: 7efedc35-88e1-4374-8cb1-188b83626f97
spl set id: 3c5f7e57-b6c7-4372-ab1e-4aa2cb8bf2f1

Reported adverse events (FAERS/openFDA)#

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