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| Product NDC Code | 10967-650 | ||||
|---|---|---|---|---|---|
| Drug Name | American crew |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SHAMPOO | ||||
| RxCUI drug identifier | 209884 | ||||
| Application Number | part358H | ||||
| Labeler Name | Revlon Consumer Products Corp | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Active Ingredients Pyrithione Zinc 1%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua (Water) (Eau), Sodium Laureth Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine, Glycerin, PEG-12 Dimethicone, Di-PPG-2 Myreth-10 Adipate, Triethanolamine, Hydroxyethylcellulose, Propylene Glycol, Sodium Chloride, Polyquaternium-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Sodium Acetate, Parfum (Fragrance), Limonene, Phenoxyethanol, Ethylparaben, Methylparaben
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: Controls itching & flaking due to 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.American Crew Pyrithione Zinc WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE GLYCERIN DI-PPG-2 MYRETH-10 ADIPATE TROLAMINE PEG-12 DIMETHICONE HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) PROPYLENE GLYCOL SODIUM CHLORIDE POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) TEA TREE OIL PEPPERMINT OIL ROSEMARY OIL SAGE OIL SODIUM ACETATE SODIUM HYDROXIDE PHENOXYETHANOL ETHYLPARABEN METHYLPARABEN PYRITHIONE ZINC PYRITHIONE ZINC
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.Label American Crew 2-In-1 Anti-Dandruff & Sebum Control Shampoo label
Instructions for use
Information about safe handling and use of the drug product.Directions • Wet hair thoroughly. • Massage a small amount of shampoo evenly into scalp and leave on for a few minutes. • Rinse well. • For best results use at least twice a week or as directed by a physician.
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
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. • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. • If condition worsens or does not improve after regular use of this product as directed, consult a physician. • Consult a physician prior to use in children under 2 years of age. • KEEP 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