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First aid beauty fab ultra repair rescue barrier balm skin protectant - Medication Information

Product NDC Code 84126-045
Drug Name

First aid beauty fab ultra repair rescue barrier balm skin protectant

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 1 g/100g
Route TOPICAL
Dosage Form CREAM
Application Number M016
Labeler Name The Procter & Gamble Manufacturing Company
Packages
Package NDC Code Description
84126-045-10 1 tube in 1 carton (84126-045-10) / 10 g in 1 tube
84126-045-30 1 tube in 1 carton (84126-045-30) / 30 g in 1 tube
84126-045-63 1 tube in 1 carton (84126-045-63) / 63.7 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Dimethicone 1%

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, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, DICAPRYLYL CARBONATE, GLYCERIN, PENTYLENE GLYCOL, CETEARYL ALCOHOL, LAURYL LAURATE, GLYCERYL STEARATE, C12-16 ALCOHOLS, COLLOIDAL OATMEAL, POLYGLYCERYL-6 OCTASTEARATE, GLYCERYL BEHENATE, BEHENYL ALCOHOL, CERAMIDE NP, CENTELLA ASIATICA EXTRACT, ALOE BARBADENSIS LEAF JUICE, PHOSPHOLIPIDS, CETYL PALMITATE, SORBITAN PALMITATE, HYDROXYACETOPHENONE, CARBOMER, PHENOXYETHANOL, CAPRYLYL GLYCOL, PALMITIC ACID, HYDROGENATED LECITHIN, TROMETHAMINE, PHYTOSTEROLS, LINOLEIC ACID, SORBITAN OLEATE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, SODIUM PHYTATE, ETHYLHEXYLGLYCERIN, TRIOLEIN, PROPANEDIOL, GLYCERYL DIOLEATE

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 prevent and temporarily protects and helps relieve chafed, chapped or cracked skin. Helps prevet and protect from the drying effects of wind and cold weather.

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 Rescue Barrier Balm Skin Protectant Dimethicone PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE DICAPRYLYL CARBONATE LAURYL LAURATE BEHENYL ALCOHOL SORBITAN PALMITATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE HYDROGENATED SOYBEAN LECITHIN LINOLEIC ACID GLYCERYL DIOLEATE PROPANEDIOL CETYL PALMITATE SORBITAN OLEATE SODIUM PHYTATE CENTELLA ASIATICA TRITERPENOIDS ALOE BARBADENSIS LEAF JUICE C12-16 ALCOHOLS HYDROXYACETOPHENONE TROMETHAMINE PENTYLENE GLYCOL ETHYLHEXYLGLYCERIN OATMEAL PALMITIC ACID CETEARYL ALCOHOL TRIOLEIN CAPRYLYL GLYCOL PHENOXYETHANOL WATER GLYCERIN DIMETHICONE DIMETHICONE GLYCERYL STEARATE CAPRYLIC/CAPRIC TRIGLYCERIDE CERAMIDE NP BUTYLENE GLYCOL

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 - 63.7 g (2.25 oz) First Aid Beauty FAB Ultra Repair® Rescue Barrier Balm Skin Protectant with 1% Dimethicone Net Wt. 63.7 g (2.25 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

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on deep puncture wounds animal bites serious burns

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.
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 Do not use on deep puncture wounds animal bites serious burns

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