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Product NDC Code | 55910-805 | ||||
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Drug Name | Gentle steps vitamins a and d diaper rash and skin protectant |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 664981 | ||||
Application Number | M016 | ||||
Labeler Name | Old East Main CO. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Lanolin 15.5% Petrolatum 53.4%
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 • for diaper rash use: • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged • for skin protectant use: apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin
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 • temporarily protects minor: • cuts • scrapes • burns • temporarily protects and helps relieve chapped or cracked skin and lips
Purpose
Information about the drug product’s indications for use.Purpose Diaper rash ointment Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Gentle STEPS vitamins A and D Diaper Rash and Skin Protectant Lanolin, Petrolatum LANOLIN LANOLIN PETROLATUM PETROLATUM COD LIVER OIL LIGHT MINERAL OIL MICROCRYSTALLINE WAX PARAFFIN
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.Packaging OldEast
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
Compare to active ingredients of A+D ® Original Ointment* • Helps treat and prevent diaper rash • Helps seal out wetness • Dye free, Paraben free & Phthalate free *This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of A+D® Original Ointment. DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 MADE IN INDIA 100% Satisfaction Guaranteed! If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied. (888) 309-9030
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? 1-888-309-9030
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20° to 25°C (68° to 77°F)
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 Do not use on • deep or puncture wounds • animal bites • serious burns 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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