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| Product NDC Code | 54136-183 | ||||
|---|---|---|---|---|---|
| Drug Name | Calming itch and irritation |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 1591951 | ||||
| Application Number | M016 | ||||
| Labeler Name | Better Planet Brands LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Colloidal Oatmeal 2.0%
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 as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients WATER, ALOE BARBADENSIS LEAF JUICE POWDER*, CETEARYL OLIVATE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, THEOBROMA CACAO (COCOA) SEED BUTTER*, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, SORBITAN OLIVATE, GLYCERIN, COCOGLYCERIDES, GLYCERYL STEARATE SE, TOCOPHEROL, HIPPOPHAE RHAMNOIDES FRUIT OIL*, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPABA (OLIVE) FRUIT OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SALVIA HISPANICA SEED OIL, CHENOPODIUM QUINOA SEED OIL, XANTHAN GUM, SQUALANE, SODIUM LEVULINATE, GLYCERYL LAURATE, POTASSIUM SORBATE, CITRIC ACID.
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 temporarily protects and helps relieve minor skin irritation and itching due to: rashes • eczema poison ivy, oak, or sumac • insect bites
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Calming Itch and Irritation Colloidal Oatmeal OLIVE OIL SUNFLOWER OIL WATER ALOE VERA LEAF HIPPOPHAE RHAMNOIDES SEED OIL SQUALANE TOCOPHEROL ANHYDROUS CITRIC ACID SORBITAN OLIVATE POTASSIUM SORBATE OATMEAL OATMEAL CHIA SEED OIL MEADOWFOAM SEED OIL SHEA BUTTER CETEARYL OLIVATE COCO-GLYCERIDES SODIUM LEVULINATE COCOA BUTTER XANTHAN GUM GLYCERYL LAURATE SAFFLOWER OIL GLYCERYL STEARATE SE GLYCERIN QUINOA OIL
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.Calming Lotion_8oz_Oxygen_CTL_OL
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Remove quality seal. Do not use if quality seal is broken. Store at room temperature.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll-free 877.902.2873
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 doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days
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 Do not get into eyes
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 When using this product Do not get into eyes Stop use and ask doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If product is 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