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| Product NDC Code | 84126-044 | ||||
|---|---|---|---|---|---|
| Drug Name | First aid beauty fab ultra repair skin protectant winter mint |
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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 | CREAM | ||||
| Application Number | M016 | ||||
| Labeler Name | The Procter & Gamble Manufacturing Company | ||||
| 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 0.5%
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.Water, Stearic Acid, Glycerin, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Glyceryl Stearate, Glyceryl Stearate SE, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Dimethicone, Squalane, Phenoxyethanol, Caprylyl Glycol, Xanthan Gum, Allantoin, Sodium Hydroxide, Mentha Arvensis (Cornmint) Oil, Tetrasodium EDTA, Mentha Spicata (Spearmint) Leaf Oil, Chrysanthemum Parthenium (Feverfew) Extract, Eucalyptus Globulus Leaf Oil, Mentha Piperita (Peppermint) Oil, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Mentha Citrata Bergamot Mint, Ceramide NP
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 eczema, rashes, 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.First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint Colloidal Oatmeal SPEARMINT OIL MENTHA ARVENSIS FLOWER OIL PEPPERMINT OIL CETEARYL ALCOHOL SQUALANE DIMETHICONE TETRASODIUM EDTA GLYCERYL STEARATE SE C12-15 ALKYL BENZOATE CAMELLIA SINENSIS LEAF CAPRYLYL GLYCOL SODIUM HYDROXIDE PHENOXYETHANOL BUTYROSPERMUM PARKII (SHEA) BUTTER GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT WATER GLYCERIN OATMEAL OATMEAL ALLANTOIN GLYCERYL STEARATE CAPRYLIC/CAPRIC TRIGLYCERIDE STEARIC ACID XANTHAN GUM CERAMIDE NP TANACETUM PARTHENIUM WHOLE EUCALYPTUS GLOBULUS LEAF OIL MENTHA AQUATICA VAR. CITRATA LEAF
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 - 56.7 g (2 oz) First Aid Beauty FAB Ultra Repair® Cream Intense Hydration Winter Mint Skin Protectant Colloidal Oatmeal Net Wt. 56.7 g (2 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
MADE IN USA FIRST AID BEAUTY LTD NEWTON, MA 02458 WWW.FIRSTAIDBEAUTY.COM
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: 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, 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.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 only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not get into eyes. Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days
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