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Product NDC Code | 49967-970 | ||||||||||
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Drug Name | Cerave developed with dermatologists itch relief moisturizing |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | LOTION | ||||||||||
Application Number | M017 | ||||||||||
Labeler Name | L'Oreal USA Products Inc | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Pramoxine hydrochloride 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: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, isopropyl myristate, PEG-100 stearate, glyceryl stearate, cetearyl alcohol, cetyl alcohol, glycerin, niacinamide, dimethicone, stearic acid, allantoin, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, zinc citrate, behentrimonium methosulfate, sodium hydroxide, sodium lauroyl lactylate, arginine PCA, myristic acid, sodium PCA, cholesterol, palmitic acid, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., tocopheryl acetate, hydrolyzed hyaluronic acid, xanthan gum, phytosphingosine, polyglyceryl-3 diisostearate, ethylhexylglycerin
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.Use For the temporary relief of itching associated with minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.CeraVe Developed with Dermatologists Itch Relief Moisturizing pramoxine hydrochloride PRAMOXINE HYDROCHLORIDE PRAMOXINE WATER ISOPROPYL MYRISTATE CETYL ALCOHOL STEARIC ACID CETOSTEARYL ALCOHOL GLYCERYL MONOSTEARATE PEG-100 STEARATE GLYCERIN DIMETHICONE NIACINAMIDE CERAMIDE 3 CERAMIDE 6 II CERAMIDE 1 PHENOXYETHANOL XANTHAN GUM BEHENTRIMONIUM METHOSULFATE POLYGLYCERYL-3 DIISOSTEARATE SODIUM HYDROXIDE ALLANTOIN ETHYLHEXYLGLYCERIN SODIUM LAUROYL LACTYLATE ARGININE PYROGLUTAMATE EDETATE DISODIUM POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC ZINC CITRATE SODIUM PYRROLIDONE CARBOXYLATE PHYTOSPHINGOSINE CHOLESTEROL MYRISTIC ACID PALMITIC ACID HYALURONIC ACID CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) .ALPHA.-TOCOPHEROL ACETATE
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.image of a front label
image of a back label
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 on ▪ deep or puncture wounds ▪ animal bites ▪ serious burns
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 immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Toll-Free Number 888-768-2915 www.cerave.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 Do not use on ▪ deep or puncture wounds ▪ animal bites ▪ serious burns
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 do not get into eyes
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 immediately.
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