FDA.reportPublic FDA data

ROLL ON MUSCLE GEL

Manufacturer
Oxigenesis, Inc
Effective date
2018-04-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:19

Label at a glance#

ProductRECOVERY BALM - ORIGINAL
Active ingredientMAGNESIUM SULFATE HEPTAHYDRATE
Label structure5 sections

Label contents#

Full prescribing information#

RECOVERY BALM COOL HEAT

WARNINGS AND PRECAUTIONS SECTION

ROLL ON MUSCULER GEL

WARNINGS

WARNINGS SECTION

  • Do not use on broken or irritated skin
  • Avoid eye contact
  • Do not store in above 120 F
  • Use as directed
  • external use only

Precautions

PRECAUTIONS SECTION

  • If pregnant or Breast feeding ask doctor before use
  • keep out of reach of children
USES

INSTRUCTIONS FOR USE SECTION

  • Prevent muscles cramp
  • Reduse muscles soreness and tightness
  • eases muscles symptoms of inflammation
Directions

INDICATIONS & USAGE SECTION

  • Shake well before use
  • Apply balm in area need of theropy
  • Rub over entire muscles group until absorbed

Inactives

INACTIVE INGREDIENT SECTION

Inactive Ingredient for Recovery Blam Original Product Label

water, magnesium chloride, hydroxypropyl starch, balm base (proprietary blend of whole leaf aloe vera concentrate, plantderived multi-mineral blend, natural plant squalene, peach kernel oil, apricot kernel oil, safflower oil, sesame seed oil, jojoba oil, rice bran oil, allantonin, sorbitan Sesquioleate, citricidal [as a preservative]), natural peppermint oil, tonka bean oil

Inactive Ingredient for Cool Heat

water, magnesium chloride, hydroxypropyl starch, balm base (proprietary blend of whole leaf aloe vera concentrate, plantderived multi-mineral blend, natural plant squalene, peach kernel oil, apricot kernel oil, safflower oil, sesame seed oil, jojoba oil, rice bran oil, allantonin, sorbitan sesquioleate, citricidal [as a preservative]), wintergreen leaf oil, camphor bark oil, peppermint leaf oil, ylang ylang flower oil, helichrysum flower oil, blue tansy flower oil,

Inactive Ingredient for Ultra

water, magnesium chloride, hydroxypropyl starch, balm base (proprietary blend of whole leaf aloe vera concentrate, plantderived multi-mineral blend, natural plant squalene, peach kernel oil, apricot kernel oil, safflower oil, sesame seed oil, jojoba oil, rice bran oil, allantonin, sorbitan sesquioleate, citricidal [as a preservative]), wintergreen leaf oil, camphor bark oil, peppermint leaf oil, ylang ylang flower oil, helichrysum flower oil, blue tansy flower oil,

Product Label Recovery Original

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

originaloriginal

Product Label Cool Heat 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cool heatcool heat

Product Label Recovery Balm Ultra

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ultraultra

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72136-002-012022-01-28C16284748780-1d6a99b39-6907-a426-e053-dadaa90af4c2ROLL ON MUSCLE GEL
72136-003-012022-01-28C16284748780-1d6a99b39-6907-a426-e053-dadaa90af4c2ROLL ON MUSCLE GEL
72136-004-012022-01-28C16284748780-1d6a99b39-6907-a426-e053-dadaa90af4c2ROLL ON MUSCLE GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72136-002-01RECOVERY BALM - ORIGINAL90 mL in 1 TUBEGEL901
72136-003-01RECOVERY BALM - COOL HEAT90 mL in 1 TUBEGEL901
72136-004-01RECOVERY BALM - ULTRA90 mL in 1 TUBEGEL901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72136-002RECOVERY BALM - ORIGINAL (MAGNESIUM SULFATE) GEL RECOVERY BALM - COOL HEAT (MAGNESIUM SULFATE) GEL RECOVERY BALM - ULTRA (MAGNESIUM SALFATE) GEL [OXIGENESIS, INC]1Legacy NDC, 1 package rows20180411_69f022ed-7592-49fe-91f6-a0a98a3feae6.zip
72136-003RECOVERY BALM - ORIGINAL (MAGNESIUM SULFATE) GEL RECOVERY BALM - COOL HEAT (MAGNESIUM SULFATE) GEL RECOVERY BALM - ULTRA (MAGNESIUM SALFATE) GEL [OXIGENESIS, INC]1Legacy NDC, 1 package rows20180411_69f022ed-7592-49fe-91f6-a0a98a3feae6.zip
72136-004RECOVERY BALM - ORIGINAL (MAGNESIUM SULFATE) GEL RECOVERY BALM - COOL HEAT (MAGNESIUM SULFATE) GEL RECOVERY BALM - ULTRA (MAGNESIUM SALFATE) GEL [OXIGENESIS, INC]1Legacy NDC, 1 package rows20180411_69f022ed-7592-49fe-91f6-a0a98a3feae6.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72136-00272136-002-01
72136-00372136-003-01
72136-00472136-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 50 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SQUALENE7QWM220FJHIACT
PERSIC OIL5M26W7T072IACT
APRICOT KERNEL OIL54JB35T06AIACT
SAFFLOWER OIL65UEH262ISIACT
SESAME OILQX10HYY4QVIACT
JOJOBA OIL724GKU717MIACT
ALLANTOIN344S277G0ZIACT
CITRUS PARADISI SEED12F08874Y7IACT
MAGNESIUM CHLORIDE TETRAHYDRATEH2K2KVE749IACT
PEPPERMINT OILAV092KU4JHIACT
DIPTERYX ODORATA SEEDD43A5L1U6LIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SQUALENE7QWM220FJHIACT
PERSIC OIL5M26W7T072IACT
APRICOT KERNEL OIL54JB35T06AIACT
SAFFLOWER OIL65UEH262ISIACT
SESAME OILQX10HYY4QVIACT
JOJOBA OIL724GKU717MIACT
ALLANTOIN344S277G0ZIACT
CITRUS PARADISI SEED12F08874Y7IACT
MAGNESIUM CHLORIDE TETRAHYDRATEH2K2KVE749IACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
PEPPERMINT OILAV092KU4JHIACT
EUCALYPTUS OIL2R04ONI662IACT
METHYL SALICYLATELAV5U5022YIACT
SWEET MARJORAM OILICH7BE016EIACT
HELICHRYSUM ARENARIUM FLOWERGN27F71368IACT
CANANGA OIL8YOY78GNNXIACT
TANACETUM VULGARE FLOWER392XZ1456QIACT
LAPONITED703131383IACT
DIPTERYX ODORATA SEEDD43A5L1U6LIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SQUALENE7QWM220FJHIACT
PERSIC OIL5M26W7T072IACT
SESAME OILQX10HYY4QVIACT
JOJOBA OIL724GKU717MIACT

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
21422049-8636-4843-80a8-fd131cec6e9f69f022ed-7592-49fe-91f6-a0a98a3feae62018-04-06WarningsExact identifier
spl id: 21422049-8636-4843-80a8-fd131cec6e9f
spl set id: 69f022ed-7592-49fe-91f6-a0a98a3feae6

Reported adverse events (FAERS/openFDA)#

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