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| Product NDC Code | 0299-4114 | ||||
|---|---|---|---|---|---|
| Drug Name | Cetaphil cracked skin repair |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 198605 | ||||
| Application Number | M016 | ||||
| Labeler Name | Galderma Laboratories, L.P. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients......Purpose Dimethicone 2%......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 ● Apply generously to affected area as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED CASTOR OIL, LACTIC ACID, METHOXY PEG-22/DODECYL GLYCOL COPOLYMER, METHYLPARABEN, MINERAL OIL, OZOKERITE, PEG-2 HYDROGENATED CASTOR OIL, PEG-7 HYDROGENATED CASTOR OIL, PROPYLPARABEN, SODIUM LACTATE, SORBITAN ISOSTEARATE, UREA, WATER
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 prevent and temporarily protects and helps relieve chafed, chapped or cracked skin ● temporary protects minor: ● cuts ● scrapes ● burns ● helps prevent and protect from the drying effects of wind and cold weather
Spl product data elements
Usually a list of ingredients in a drug product.Cetaphil Cracked Skin Repair Dimethicone Dimethicone Dimethicone Medium-Chain Triglycerides Hydrogenated Castor Oil Lactic Acid, Unspecified Form Methoxy Peg-22/Dodecyl Glycol Copolymer Methylparaben Mineral Oil Ceresin Peg-7 Hydrogenated Castor Oil Propylparaben Sodium Lactate Sorbitan Isostearate Urea Water Cet Cracked skin lotion P56383-1
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.PRINCIPLE DISPLAY PANEL - 16 FL OZ pump label Dermatologist Recommended For Sensitive Skin Cetaphil ® Cracked Skin Repair Lotion Skin Protectant Dimethicone Rough, Cracked Sensitive Skin Daily use lotion is designed to hydrate and restore rough skin and prevent cracked skin from coming back. Urea 5 skin sensitivity signs 16 FL OZ (473 mL) P56383-1
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? 1-866-735-4137 Distributed By: Galderma Laboratories, L.P. Dallas, TX 75201 All trademarks are the property of their respective owners. Made in Canada cetaphil.com
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. Do not use on ● deep or puncture wounds ● animal bites ● serious burns 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