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Product NDC Code | 70411-102 | ||||
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Drug Name | Nothing |
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Type | Brand | ||||
Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
Application Number | M017 | ||||
Labeler Name | H2Ocean, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Lidocane hydrochloride, 4%
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 1-2 pumps of the foam soap to the affected area 3-4 times daily. Children under 2 years of age: consult a doctor. For best results, do not use with alcohol based products.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Purified water, Poloxamer, Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Disodium ETDA, Sea Salt
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/or itching associated with minor skin irritations
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.Nothing Lidocaine LIDOCAINE LIDOCAINE WATER POLOXAMER 124 ALOE VERA LEAF BENZALKONIUM CHLORIDE DISODIUM ETHYLENEDIAMINEDIACETATE SODIUM CHLORIDE
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.H2Ocean(r) First In First Aid (TM) NOTHING (TM) Pain Relieving Soap with Lidocaine Anesthetic 1.7 Fl. Oz. (50 ml.) 20180130 102 H2Ocean Nothing
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.Questions? 1-888-420-2326
H2Ocean (r) First In First Aid (TM) H2Ocean's Nothing is the choice for first aid when ou want to feel NOTHING. H2Ocean, LLC, Stuart, FL, USA H2Ocean Europe SRL LTD., Waterford, Ireland USA / EU +1 772.219.8183 [email protected] Made in USA www.H2Ocean.com
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 large quantities, particularly on raw surfaces of blistered areas.
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.
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.If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.
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. In case of eye contact, flush eyes with water.
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. In case of eye contact, flush eyes with water. Do not use in large quantities, particularly on raw surfaces of blistered areas. If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.
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