Otc - Active Ingredient
MENTHOL
Aquacool Red Roll
FDA Label NDC 70759-0005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmanuco for the product Aquacool Red Roll (NDC 70759-0005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
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
To relieve pain
Otc - Keep Out Of Reach Of Children
keep out of reach of the children
Indications & Usage
Apply proper amount to desired area(s) and massage the applied area until it's absorbed to the skin thoroughly.
Dosage & Administration
for external use only
Warnings
- Under normal room conditions, the shelf life is estimated at 2 years.
- Recommended Use: Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, arthritis, strains, bruises, sprains.
- Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
- Rub in thoroughly until gel is absorbed.
- Use with caution on sensitive areas.
- It is recommended that you do a patch test before applying liberally to the skin.
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
