AQUACOOL SHOWER

Manufacturer
Pharmanuco
Effective date
2021-03-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:51

Label at a glance#

ProductAQUACOOL SHOWER
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

MENTHOL

INACTIVE INGREDIENT SECTION

Alcohol, Camphor, Eucalyptus Globulus Leaf Oil, Leptospermum Petersonii Oil, Fragrance

OTC - PURPOSE SECTION

To relieve pain

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children


INDICATIONS & USAGE SECTION

  1. Shake well before use.
  2. Hold can more than 20 cm away from treatment area.
  3. Apply using a sweeping motion.

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
282805menthol 2.5 % Topical GelPSN2
282805menthol 0.025 MG/MG Topical GelSCD2
282805menthol 2.5 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70759-0009-12022-07-29C16284748780-1ba0f9c33-4aab-a910-e053-dadaa90a0b85Drug Facts
70759-0009-12021-03-10C16284748780-1ba0f9c33-4aab-a910-e053-dadaa90a0b85Drug Facts
70759-0009-12021-01-29C16284748780-1ba0f9c33-4aab-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70759-0009-1AQUACOOL SHOWER200 mL in 1 BOTTLEGEL2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70759-0009AQUACOOL SHOWER (MENTHOL) GEL [PHARMANUCO]2Legacy NDC, 1 package rows20210311_35fc786c-9b06-697d-e054-00144ff88e88.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
70759-000970759-0009-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
bd28bb54-df2c-440b-e053-2995a90a56a035fc786c-9b06-697d-e054-00144ff88e882021-03-10WarningsExact identifier
spl id: bd28bb54-df2c-440b-e053-2995a90a56a0
spl set id: 35fc786c-9b06-697d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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