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Natureplex diaper rash - Medication Information

Product NDC Code 67234-001
Drug Name

Natureplex diaper rash

Type Brand
Active Ingredients
Zinc oxide 400 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 244638
Application Number part347
Labeler Name Natureplex LLC
Packages
Package NDC Code Description
67234-001-01 1 tube in 1 box (67234-001-01) / 42.5 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc Oxide 40%

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 allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients aloe barbadensis leaf juice, BHA, cetyl alcohol, coconut butter, corn starch, fragrance, hydroxyethylcellulose, lanolin, methylparaben, mineral oil, petrolatum, polysorbate 20, purified water, shea butter

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 due to diaper rash and helps seal out 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.
Natureplex Diaper Rash ZINC OXIDE ZINC OXIDE ZINC OXIDE ALOE VERA LEAF BUTYLATED HYDROXYANISOLE CETYL ALCOHOL COCOA BUTTER STARCH, CORN HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) LANOLIN METHYLPARABEN MINERAL OIL PETROLATUM POLYSORBATE 20 WATER SHEA BUTTER

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.
PRINCIPAL DISPLAY PANEL - 42.5 g Tube Box Natureplex™ Diaper Rash Cream 40% Zinc Oxide with Aloe for babies NET WT. 1.5 Oz. (42.5g) Principal Display Panel - 42.5 g Tube Box

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: 800-222-1222.

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? 866-323-0107 or www.natureplex.com

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 ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 15 to 30°C (59 to 86°F) Tamper Evident : DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

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. Avoid contact with 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

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