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First aid beauty anti-dandruff - Medication Information

Product NDC Code 69423-591
Drug Name

First aid beauty anti-dandruff

Type Brand
Active Ingredients
Pyrithione zinc 1 g/100ml
Route TOPICAL
Dosage Form SHAMPOO
RxCUI drug identifier 209884
Application Number M032
Labeler Name The Procter & Gamble Manufacturing Company
Packages
Package NDC Code Description
69423-591-23 236.5 ml in 1 bottle, plastic (69423-591-23)
69423-591-30 30 ml in 1 bottle, plastic (69423-591-30)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Pyrithione zinc 1.00%

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 Shake before use. Wet hair, massage onto scalp. Leave on for several minutes. Rinse. Repeat if desired Follow with conditioner For best results use at least twice a week or as directed by a doctor For effective control, use every time you shampoo.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, sodium cocoyl isethionate, cocamidopropyl betaine, acrylates copolymer, sodium methyl cocoyl taurate, glycol distearate, sodium chloride, glycerol, sodium cocoyl glycinate, phenoxyethanol, guar hydroxypropyl­trimonium chloride, sorbitan oleate decylglucoside crosspolymer, sodium hydroxide, coconut acid, sodium cocoate, calendula officinalis flower extract, caprylyl glycol, chamomilla recutita (matricaria) flower extract, colloidal oatmeal, decylene glycol, citrus aurentium dulcis (orange) peel extrect, citrus paredisi (grepefruit) fruit extract, lavandula angustifolia (lavender) flower􀀭eaf/stem extract, mangifera indica (mango) fruit extract, pyrus malus (apple) fruit extract, linalool, maltodextrin, cocos nucifera (coconut) oil, DL-panthenol, DL-alpha tocopheryl acetate, chrysanthemum parthenium (feverfew) extract, helianthus annuus (sunflower) seed oil, cocos nucifera (coconut) fruit extract, cucumis melo (melon) fruit extract, mentha piperita (peppermint) leaf extract, prunus armeniaca (apricot) kernel extract, prunus persica (peach) fruit extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, hydrolyzed silk, gardenia jasminoides fruit extract, annafto, citrus aurantium bergamia (bergamot) fruit extract, rubus idaeus (respberry) fruit extract, ascorbyl palmitate, d-alpha tocopherol, ethylhexylglycerin, tetrasodium EDTA

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 helps eliminate and reduces recurrence of the symptoms of dandruff.

Purpose

Information about the drug product’s indications for use.
Purpose Anti-dandruff

Spl product data elements

Usually a list of ingredients in a drug product.
First Aid Beauty Anti-Dandruff Pyrithione Zinc COCAMIDOPROPYL BETAINE WATER SODIUM COCOYL ISETHIONATE ACRYLATES CROSSPOLYMER-6 GLYCOL DISTEARATE SODIUM METHYL COCOYL TAURATE SODIUM CHLORIDE SODIUM COCOYL GLYCINATE SODIUM HYDROXIDE COCONUT ACID SODIUM COCOATE CALENDULA OFFICINALIS FLOWER GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) CAPRYLYL GLYCOL CHAMOMILE PYRITHIONE ZINC PYRITHIONE ZINC ORANGE PEEL TANACETUM PARTHENIUM WHOLE .ALPHA.-TOCOPHEROL ACETATE, DL- COCONUT SUNFLOWER OIL MENTHA PIPERITA LEAF PHENOXYETHANOL PRUNUS ARMENIACA SEED RASPBERRY ASCORBYL PALMITATE .ALPHA.-TOCOPHEROL, D- MUSKMELON ANNATTO OATMEAL MANGO APPLE LINALOOL, (+/-)- MALTODEXTRIN COCONUT OIL PANTHENOL GREEN TEA LEAF GLYCYRRHIZA GLABRA BERGAMOT OIL ETHYLHEXYLGLYCERIN EDETATE SODIUM GLYCERIN GARDENIA JASMINOIDES FRUIT DECYLENE GLYCOL GRAPEFRUIT LAVANDULA ANGUSTIFOLIA FLOWERING TOP GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) PEACH

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.
PRINCIPAL DISPLAY PANEL - 236.5 mL Bottle Label First Aid Beauty® FAB 1% pyrithione zinc dandruff shampoo Sulfate-Free Safe For Color-Treated Hair Safe for Sensitive Skin Dermatologist Tested No Artificial Fragrance 236.5 mL (8.0 FL OZ) FAB

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.
Drug Facts Dist. by FIRST AID BEAUTY LTD Newton, MA 02458

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 this and all drugs 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 (or comments)? 888-FAB-3063

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 condition worsens or does not improve after regular use of this product as directed.

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 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.
Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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