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| Product NDC Code | 54973-4101 | ||||
|---|---|---|---|---|---|
| Drug Name | Hylands naturals diaper rash cream |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 248279 | ||||
| Application Number | part347 | ||||
| Labeler Name | Hylands | ||||
| 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 ingredients Purpose Zinc Oxide 10%.................................... skin protectant
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 ■ Change wet and soiled diapers promptly. ■ Cleanse the diaper area and allow to dry. ■ Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Organic Aloe (Aloe Barbadensis) Leaf Extract, Organic Beeswax, Organic Calendula Officinalis Flower Extract, Organic Castor (Ricinus Communis) Seed Oil, Organic Matricaria (Chamomilla Recutita) Flower Extract, Organic Sunflower (Helianthus Annuus) Seed Oil, Tocopherol.
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 ■ Helps treat and prevent diaper rash. ■ Protects chafed skin associated with diaper rash and helps protect from wetness.
Purpose
Information about the drug product’s indications for use.Purpose Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Hylands Naturals Diaper Rash Cream ZINC OXIDE ZINC OXIDE ZINC CATION ALOE VERA LEAF WHITE WAX CALENDULA OFFICINALIS FLOWER CASTOR OIL MATRICARIA CHAMOMILLA FLOWERING TOP SUNFLOWER OIL TOCOPHEROL
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.Package Labeling Hylands NATURALS • baby • DIAPER RASH CREAM Helps Soothe, Treat and Prevent Diaper Rash PEDIATRICIAN TESTED DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING. Manufactured for: Hyland’s, Inc. Los Angeles, CA 90061 www.hylands.com Certified Organic by Oregon Tilth res Hylands DiapRash
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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? www.hylands.com or [email protected]
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. When using this product do not get into eyes. Stop use and ask a doctor if: ■ condition worsens. ■ symptoms last more than 7 days or clear up and occur again within a few days.
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