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Product NDC Code | 49348-030 | ||||
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Drug Name | Sunmark isopropyl rubbing alcohol |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 808520 | ||||
Application Number | M003 | ||||
Labeler Name | Strategic Sourcing Services LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Isopropyl Alcohol 70% U.S.P. by volume
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 antiseptic use: Apply a small amount of this product to the affected area 1 to 3 times daily. May be covered with sterile bandage. If bandaged let dry first. For rubbing or massage use: Apply compound externally on body until liquid has been absorbed or has been evaporated.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient: Purified 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 First aid to help prevent infection in minor cuts, scrapes, and burns. For rubbing massage and as an external stimulant.
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.sunmark Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL
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.sunmark Isopropyl Rubbing Alcohol 70% USP First aid antiseptic to help prevent infection in minor cuts, scrapes, and burns For rubbing, massaging and sponge baths. WARNING: FLAMMABLE, KEEP AWAY FROM SPARK, HEAT OR FLAME Distributed by McKesson, One Post Street, San Francisco, CA 94104 Money Back Guarantee 128 FL OZ (1 GAL) 3.8 L
sunmark Isopropyl Alcohol 70% USP 128oz (49348-030-40) Isopropyl Alcohol
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.sunmark Isopropyl Alcohol 70% USP
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
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 apply over a large area of the body when used as an antiseptic.
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. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. In case of eye contact, flush eyes with running water for 15 minutes.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: FLAMMABLE: Keep away from spark, heat and flame. NOTICE: This product does not contain eithyl or grain alcohol and is not sold as a substitute for preparations containing ethyl or grain alcohol.
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 consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor. Discontinue use if excessive irritation of the skin develops.
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 apply to irritated skin and avoid getting into eyes or mucous membranes.
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. USE IN WELL VENTILATED AREA. FUMES MAY BE HARMFUL. Do not use in the eyes or apply over a large area of the body when used as an antiseptic. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. When using this product: Do not apply to irritated skin and avoid getting into eyes or mucous membranes. Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor. Discontinue use if excessive irritation of the skin develops. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. In case of eye contact, flush eyes with running water for 15 minutes.
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