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| Product NDC Code | 31507-876 | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Hand guard high foaming antiseptic hand and body wash |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||||||||||||||||||||||||||||
| Dosage Form | SOAP | ||||||||||||||||||||||||||||||||||||||||||||||||
| RxCUI drug identifier | 413261 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number | part333E | ||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler Name | Wechem, Inc. | ||||||||||||||||||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Box OTC-Active Ingredient Section Chloroxylenol 0.3%
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.Drug Facts Box OTC-Dosage & Administration Section wet hands and forearms apply 5 milliliters (teaspoonful) or palmful to hands and forearms scrub thoroughly for 1 minute and rinse
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Drug Facts Box OTC-Inactive Ingredient Section water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, DMDM hydantoin, fragrance, methylchloroisothiazolinone, methylisothiazolinone, aloe barbadensis, acid red 1
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.Drug Facts Box OTC-Indications & Usage Section for hand-washing to decrease bacteria on the skin
Purpose
Information about the drug product’s indications for use.Drug Facts Box OTC-Purpose Section Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Hand Guard High Foaming Antiseptic Hand and Body Wash CHLOROXYLENOL CHLOROXYLENOL CHLOROXYLENOL WATER PROPYLENE GLYCOL SODIUM LAURETH SULFATE DECYL GLUCOSIDE ACID RED 1 METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE DMDM HYDANTOIN ALOE VERA LEAF
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.Hand Guard High Foaming Antiseptic Hand & Body Wash 6876 Hand Guard High Foaming Hand and Body Wash product label
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.Drug Facts Box OTC-Keep Out of Reach of Children Section if swallowed, get medical help or contact a Poison Control Center right away
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.Drug Facts Box OTC-Stop Use Section irritation and redness develop
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.Drug Facts Box OTC-When Using Section do not get into eyes if contact occurs, rinse eyes thoroughly 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.Drug Facts Box OTC-Warnings Section 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