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Product NDC Code | 80714-034 | ||||
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Drug Name | Clorox hand sanitizer gel |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 581662 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | New Wave Global Services Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Alcohol 70% v/v
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 Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Acrylates/Vinyl Isodecanoate Crosspolymer (10000 MPA.S Neutralized at 0.5%), Aloe Vera Leaf Extract, Propylene Glycol, Isopropyl Myristate, Fragrance, Vitamin E Acetate, Yellow 10, Yellow 5, Blue 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.Use Hand Sanitizer to help reduce bacteria on the skin.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.CLOROX Hand sanitizer Gel Alcohol hand Sanitizer ALOE VERA LEAF FD&C YELLOW NO. 5 FD&C BLUE NO. 1 D&C YELLOW NO. 10 WATER PROPYLENE GLYCOL ISOPROPYL MYRISTATE ALOE ALPHA-TOCOPHEROL ACETATE ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) ALCOHOL 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.Package Label - Principal Display Panel clorox HS 4OZx12 Carton, NDC:80714-034-04 CLOROX HS 4OZ Tube, NDC: 80714-034-02 CLOROX HS Gallon Jug- NDC 80714-034-08 CLOROX HS Pouch-NDC 80714-034-05 CLOROX HS 24x Single Use Pouches Carton - NDC 80714-034-06 CLOROX HS 12X2oz Tube Display Carton- NDC 80714-034-03 CLOROX HS 2OZ Tube-NDC 80714-034-01 6 x 12 oz Bottles CLOROX Hand Sanitizer Gel 12 Oz Bottle-NDC: 80714-034-10 Clorox Hand Sanitizer Gel 8 Oz Bottle-NDC: 80714-034-09 CLOROX HS 4OZX12 CARTON Clorox HS 4OZ Tube CLOROX HS Gallon Jug Clorox HS Pouch- NDC 80714-034-05 24x Single Use Pouces Carton NDC 80714-034-06 12x2 oz Tubes Display Carton Clorox Hand Sanitizer Gel - 2oz Tube Label NDC: 80714-034-01 6 x 12 oz Bottles
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.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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 children less than 2 months of age on open skin wounds
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? 1-888-325-6769 24 hours, 7 days per week www.cloroxhandsanitizer.com
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 irritation or rash occurs. These may be signs of a serious condition.
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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
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. Flammable. Keep away from heat or flame
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