Otc - Active Ingredient
Camphor..............0.5 %
Menthol...............1.25 %
Priyal Ice Gel
FDA Label NDC 72822-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Priyal Cosmetics for the product Priyal Ice Gel (NDC 72822-016). 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, otc - purpose, dosage & administration, indications & usage, otc - keep out of reach of children, warnings, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Menthol 1.25 %................Topical Analgesic
Camphor 0.5 %...............Topical Analgesic
Dosage & Administration
- Clean affected area before applying product
- Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- Children under 2 years of age: ask a doctor
Indications & Usage
Uses:
temporarily relieves minor aches and pains of muscles and joints associated with:
- arthritis
- simple backache
- strains
- bruises
- sport injuries
- sprains
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Warnings
For external use only.
Do not use
- with other topical pain relivers
- with heating pads or heating devices
- do not use in or near the eyes
- do not apply to wounds or damaged skin
- do not bandage tightly
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- redness or iritation develops
When using this product
Stop use and ask a doctor if:
It pregnant or breast-feeding, ask a health professional before use.
Inactive Ingredient
Aqua, Propylene Glycol, Carbomer, Methyl Salicylate, Sodium Hydroxide, Sodium Methyl Paraben, Sodium Propylene Paraben, FD&C Blue #1 Cl 42090
Other Safety Information
Other information
- Store at room temperature 59-86 F (15-30 C)
- Keep jar tightly closed and away from open heat or flame
* Please review the disclaimer below.
