Otc - Active Ingredient
Active Ingredient
Hydrocortisone 1%
Aquaphor Itch Relief Ointment
FDA Label NDC 10356-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beiersdorf Inc for the product Aquaphor Itch Relief (NDC 10356-120). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anti-Itch Ointment
Indications & Usage
Uses
• for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema
• insect bites
• soaps
• poison ivy, oak, sumac
• seborrheic dermatitis
• psoriasis
• detergents
• cosmetics
• jewelry
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
• for the treatment of diaper rash. Consult a doctor.
Otc - When Using
When using this product
• avoid contact with eyes
• do not exceed the recommended daily dosage unless directed by a doctor
Otc - Stop Use
Stop use and consult a doctor if
• condition worsens, if symptoms persist for more than 7 days or clear
up and occur again within a few days,
and do not begin use of any other hydrocortisone product unless you have asked a doctor
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.
Dosage & Administration
Directions
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: Do not use, consult a doctor.
Inactive Ingredient
Inactive ingredients
Petrolatum, Mineral Oil, Ceresin, Lanolin Alcohol,
Panthenol, Glycerin, Bisabolol, Menthoxypropanediol
Otc - Questions
Questions or comments?
1-800-227-4703
Package Label.Principal Display Panel
Aquaphor Itch Relief Ointment
1% Hydrocortisone Anti-Itch Ointment
Maximum Strength
Immediately Soothes & Relieves Itch & Irritiation
Skin irritation
Skin Rashes
Insect Bites
Eczema
Psoriasis
Poison Ivy
Up to 12 hours Significant Itch Relief
Clinically Proven
Dermatologist Recommended Brand
Helps Heal the Itch
Lasts up to 12 hours
Immediately soothes itchy spots to help skin heal
Fragrance free and Paraben free
Aquaphoritchreliefctn (Aquaphoritchreliefcrtn)
* Please review the disclaimer below.
