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Product NDC Code | 49825-131 | ||||||
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Drug Name | Spotless cleanser bioelements |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
RxCUI drug identifier | 317152 | ||||||
Application Number | part333D | ||||||
Labeler Name | Bioelements, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Salicylic Acid 2% Acne treatment Uses for the treatment of acne Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. When using this product: Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs only use one topical acne medication at a time. Warnings For external use only Directions Apply one pump to wet skin and massage over face avoiding eye area, rinse off. Use morning and night If dryness or peeling occurs, reduce usage to once a day. Inactive ingredients Water (Aqua, Eau), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Citrate, Ananas Sativus (Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Panthenol, Allantoin, PEG-150 Distearate, Sodium Chloride.
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 Apply one pump to wet skin and massage over face avoiding eye area, rinse off. Use morning and night If dryness or peeling occurs, reduce usage to once a day. Inactive ingredients Water (Aqua, Eau), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Citrate, Ananas Sativus (Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Panthenol, Allantoin, PEG-150 Distearate, Sodium Chloride.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua, Eau), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Citrate, Ananas Sativus (Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Panthenol, Allantoin, PEG-150 Distearate, Sodium Chloride.
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.When using this product: Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs only use one topical acne medication at a time. Warnings For external use only Directions Apply one pump to wet skin and massage over face avoiding eye area, rinse off. Use morning and night If dryness or peeling occurs, reduce usage to once a day. Inactive ingredients Water (Aqua, Eau), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Citrate, Ananas Sativus (Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Panthenol, Allantoin, PEG-150 Distearate, Sodium Chloride.
Purpose
Information about the drug product’s indications for use.Uses for the treatment of acne Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. When using this product: Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs only use one topical acne medication at a time. Warnings For external use only Directions Apply one pump to wet skin and massage over face avoiding eye area, rinse off. Use morning and night If dryness or peeling occurs, reduce usage to once a day. Inactive ingredients Water (Aqua, Eau), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Citrate, Ananas Sativus (Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Panthenol, Allantoin, PEG-150 Distearate, Sodium Chloride.
Spl product data elements
Usually a list of ingredients in a drug product.Spotless Cleanser Bioelements Salicylic Acid SALICYLIC ACID SALICYLIC ACID WATER SODIUM C14-16 OLEFIN SULFONATE COCAMIDOPROPYL BETAINE GLYCERIN LAURYL GLUCOSIDE SODIUM CITRATE PINEAPPLE PAPAYA PANTHENOL ALLANTOIN PEG-150 DISTEARATE SODIUM CHLORIDE
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.Bioelements Acne Clearing System Spotless Cleanser 2% salicylic acid acne cleanser Cleanses deep to clear and heal acne Primary Secondary 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.Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. When using this product: Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs only use one topical acne medication at a time. Warnings For external use only Directions Apply one pump to wet skin and massage over face avoiding eye area, rinse off. Use morning and night If dryness or peeling occurs, reduce usage to once a day. Inactive ingredients Water (Aqua, Eau), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Citrate, Ananas Sativus (Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Panthenol, Allantoin, PEG-150 Distearate, Sodium Chloride.
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 Directions Apply one pump to wet skin and massage over face avoiding eye area, rinse off. Use morning and night If dryness or peeling occurs, reduce usage to once a day. Inactive ingredients Water (Aqua, Eau), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Citrate, Ananas Sativus (Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Panthenol, Allantoin, PEG-150 Distearate, Sodium Chloride.
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