FDA.reportPublic FDA data

AQUACOOL RED 500

Manufacturer
Pharmanuco
Effective date
2016-06-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:46:23

Label at a glance#

ProductAQUACOOL RED 500
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

MENTHOL

INACTIVE INGREDIENT SECTION

WATER, GLYCERIN, CABORBER, ACETYL GLUCOSAMINE, IPA, CAMPHOR, METHILPARABEN, KONIO NP-12, RHEODOL O120, EUCALYPTUS OIL, VANILLYL BUTYL ETER, SF1202, LEMON SCENTED TEA TREE OIL, RED102, SODIUM HYDROXIDE, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, LEPTOSPERMUM PETERSONII OIL, ARNICA MONTANA FLOWER EXTRACT

OTC - PURPOSE SECTION

To relieve pain

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children


INDICATIONS & USAGE SECTION

Apply proper amount to desired area(s) and massage the applied area until it's absorbed to the skin thoroughly.

DOSAGE & ADMINISTRATION SECTION

for external use only


WARNINGS SECTION

  1. Under normal room conditions, the shelf life is estimated at 2 years.
  2. Recommended Use: Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, arthritis, strains, bruises, sprains.
  3. Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  4. Rub in thoroughly until gel is absorbed.
  5. Use with caution on sensitive areas.
  6. It is recommended that you do a patch test before applying liberally to the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259150menthol 3 % Topical GelPSN3
259150menthol 0.03 MG/MG Topical GelSCD3
259150menthol 3 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70759-0007-12021-01-29C16284748780-1ba0f9c33-54fe-a910-e053-dadaa90a0b85Drug Facts
70759-0007-22021-01-29C16284748780-1ba0f9c33-54fe-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70759-0007-1AQUACOOL RED 500120 mL in 1 BOTTLE, PUMPGEL1203
70759-0007-2AQUACOOL RED 500500 mL in 1 BOTTLE, PUMPGEL5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70759-0007AQUACOOL RED 500 (MENTHOL) GEL [PHARMANUCO]3Legacy NDC, 2 package rows20160627_35fbc9b0-e466-5717-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70759-000770759-0007-1, 70759-0007-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
VANILLYL BUTYL ETHERS2ULN37C9RIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AACTIB

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
363dbb18-7e84-0255-e054-00144ff8d46c35fbc9b0-e466-5717-e054-00144ff8d46c2016-06-27WarningsExact identifier
spl id: 363dbb18-7e84-0255-e054-00144ff8d46c
spl set id: 35fbc9b0-e466-5717-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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