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| Product NDC Code | 0316-0229 | ||||
|---|---|---|---|---|---|
| Drug Name | Sarna |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 200176 | ||||
| Application Number | M017 | ||||
| Labeler Name | Crown Laboratories | ||||
| 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 Camphor 0.5% Menthol 0.5%
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 to open, hold cap tightly and turn pump counter-clockwise 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 carbomer homopolymer type C, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl monostearate, isopropyl myristate, petrolatum, PEG-8 stearate, PEG-100 stearate, purified water, sodium hydroxide, stearic acid
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 for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac
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.Sarna camphor and menthol CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CETYL ALCOHOL DMDM HYDANTOIN GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE PETROLATUM WATER SODIUM HYDROXIDE STEARIC ACID CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL, UNSPECIFIED FORM MENTHOL POLYOXYL 8 STEARATE POLYOXYL 100 STEARATE
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 NDC 0316-0229-75 #1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND Steroid-Free Sarna ORIGINAL Camphor 0.5%, Menthol 0.5% EXTERNAL ANALGESIC LOTION ITCH RELIEF Cools and soothes itch associated with: Insect Bites Poison Ivy Sunburn Net wt. 7.5 fl oz (222 mL) P11706.01 Sarna is registered trademark of Crown Laboratories, Inc. Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 ©2019 Crown Laboratories, Inc. p1170601
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Formatted Uses section Foramtted Directions section
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature].
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 ? Call 1-833-279-6522
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 persist for more than 7 days or clear up and occur again within a few days.
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 avoid contact with the eyes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health care professional before use.
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 avoid contact with the eyes Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding, ask a health care professional before use. 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