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| Product NDC Code | 10356-120 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Aquaphor itch relief |
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| Type | Brand | ||||||||||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||
| Dosage Form | OINTMENT | ||||||||||||||
| RxCUI drug identifier | 203105, 2462510 |
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| Application Number | M017 | ||||||||||||||
| Labeler Name | Beiersdorf Inc | ||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Hydrocortisone 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Petrolatum, Mineral Oil, Ceresin, Lanolin Alcohol, Panthenol, Glycerin, Bisabolol, Menthoxypropanediol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Anti-Itch Ointment
Spl product data elements
Usually a list of ingredients in a drug product.Aquaphor Itch Relief Hydrocortisone HYDROCORTISONE HYDROCORTISONE 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL MINERAL OIL CERESIN LANOLIN ALCOHOLS GLYCERIN PANTHENOL LEVOMENOL PETROLATUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Aquaphor Itch Relief Ointment Maximum Strength Immediately Soothes & Relieves Itch & Irritiation Up to 12 hours Significant Itch Relief Clinically Proven 1% Hydrocortisone Anti-Itch Ointment Dermatologist Recommended Brand Fragrance free and Paraben free Hypoallergenic Helps Heal the Itch Clinically proven significant itch relief for up to 12 hours Immediately soothes itchy spots to help skin heal Skin irritation Skin rashes Eczema Psoriasis Eczema Poison Ivy Children's Aquaphor Itch Relief Ointment Ages 2 Years and Older Immediately Soothes & Relieves Itch & Irritiation Up to 12 hours Significant Itch Relief Clinically Proven Number 1 Pediatrician Recommended Brand for Eczema 1% Hydrocortisone Anti-Itch Ointment Dermatologist Recommended Brand Fragrance free and Paraben free Hypoallergenic Helps Heal the Itch Clinically proven significant itch relief for up to 12 hours Immediately soothes itchy spots to help skin heal Eczema Skin irritation Skin rashes Psoriasis Eczema Poison Ivy aqitchreliefcarton aqchilditchreliefcarton
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use • for the treatment of diaper rash. Consult a doctor.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-227-4703
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • avoid contact with eyes • do not exceed the recommended daily dosage unless directed by a doctor
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API