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| Product NDC Code | 52031-0876 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Dettol first aid antiseptic |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | CUTANEOUS | ||||||||
| Dosage Form | LIQUID | ||||||||
| Application Number | 505G(a)(3) | ||||||||
| Labeler Name | Reckitt Benckiser (UK) Ltd. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Chloroxylenol 4.8%
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 Clean the affected area Do not use undiluted Apply a small amount of this product on the area 1 to 3 times daily For antiseptic treatment of minor cuts, burns and scrapes: dilute 1:20 in water If bandaged, let dry first
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Caramel, castor oil, caustic soda, isopropyl alcohol, pine oil, 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.
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.Dettol First Aid Antiseptic chloroxylenol CARAMEL CASTOR OIL SODIUM HYDROXIDE ISOPROPYL ALCOHOL WHITE PINE OIL WATER CHLOROXYLENOL CHLOROXYLENOL
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.Package Label - Principal Display Panel Dettol LIQUID CHLOROXYLENOL 4.8% FIRST AID ANTISEPTIC NET WT.: 16.9 FL. OZ. (500 mL) 3224889 Dettol Liquid Chloroxylenol 4.8% First Aid Antiseptic Net wt.16.9 FL. OZ (500ml) www.rbnainfo.com DETTOL ® and the Sword device are registered trademarks. reckitt Manufacturer Reckitt Benckiser Healthcare(UK) Limited Hull HU8 7DS +44 1482 326151 Made in England 3224888 500 ml bottle front 500 mL bottle back
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor before use if you have eczema or a similar skin condition.
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 large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
Do not use this product if you are allergic to chloroxylenol or any of the ingredients on children below 1 years of age around cats or cavies undiluted on human or pet skin as severe irritation may occur after the expiry date printed on the bottle
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 the 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? 1-800-228-4722
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.
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.First Aid to help prevent infection of minocutsscrapesburns
When using this product if contact is made with eyes, wash thoroughly with cold water and consult your doctor.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store below 86°F
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.
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