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| Product NDC Code | 0316-0234 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sarna |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | M017 | ||||||
| Labeler Name | Crown Laboratories, Inc | ||||||
| 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 Menthol 0.5% 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 to open, hold cap and turn pump 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: do not use, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, Butylene Glycol, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Sodium Hydroxide, Stearic Acid, Tocopherol, 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 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 Pramoxine Hydrochloride, Menthol YEAST .BETA.-D-GLUCAN PEG-100 STEARATE BENZYL ALCOHOL CAPRYLYL GLYCOL TOCOPHEROL WATER PENTYLENE GLYCOL GLYCERYL MONOSTEARATE BUTYLENE GLYCOL CETYL ALCOHOL ETHYLHEXYLGLYCERIN ISOPROPYL MYRISTATE PRAMOXINE HYDROCHLORIDE PRAMOXINE HAMAMELIS VIRGINIANA LEAF ALOE VERA LEAF PEG-8 STEARATE DIMETHICONE GLYCERIN PALMITIC ACID SODIUM HYDROXIDE STEARIC ACID MENTHOL MENTHOL CARBOMER HOMOPOLYMER TYPE C
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.Sarna Calm + Cool Principal Display Panel #1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND Sarna Pramoxine Hydrochloride 1% Menthol 0.5% External Analgesic Lotion Steroid Free CALM + COOL ANTI-ITCH LOTION Eases pain and itch associated with insect bites, sunburn, and poison ivy Infused with Witch Hazel Extract Cools with Menthol NET WT. 7.5fl oz (222 ml) P12288.00 Sarna Calm_Cool
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 in the eyes or nose over large areas of the body for prolonged periods
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? 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 redness, irritation, swelling, or pain persists or increases.
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. if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]
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 in the eyes or nose over large areas of the body for prolonged periods When using this product avoid contact with the eyes. if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases. 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