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Hello bello kids soothing itch skin protectant - Medication Information

Product NDC Code 66163-1006
Drug Name

Hello bello kids soothing itch skin protectant

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]
Active Ingredients
Oatmeal 10 g/100g
Route TOPICAL
Dosage Form STICK
RxCUI drug identifier 1745093
Application Number part347
Labeler Name Cosmetic Solutions LLC
Packages
Package NDC Code Description
66163-1006-1 14.17 g in 1 container (66163-1006-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Colloidal Oatmeal 10%

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 Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil Organic , Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Mentha Piperita (Peppermint) Oil, Butyrospermum Parkii (Shea) Butter, Myrica Cerifera (Bayberry) Fruit Wax, Copernicia Cerifera (Carnauba) Wax, Tocopherol, Olea Europaea (Olive) Fruit Oil, Beta-Sitosterol, Calendula Officinalis Flower, Squalene, Citric Acid, Limonene

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: insect bites rashes poison ivy, oak, or sumac.

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.
hello bello Kids Soothing Itch Skin Protectant OATMEAL OATMEAL OATMEAL SUNFLOWER OIL COCONUT OIL CANDELILLA WAX CASTOR OIL PEPPERMINT OIL SHEA BUTTER MORELLA CERIFERA FRUIT WAX CARNAUBA WAX TOCOPHEROL OLIVE OIL .BETA.-SITOSTEROL CALENDULA OFFICINALIS FLOWER SQUALENE CITRIC ACID MONOHYDRATE

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 - 14.17 g Stick Label VEGAN hello bello For Insect Bites + Rashes Kids Soothing Itch Stick Skin Protectant Made with Calendula and Peppermint Oils NET WT. 0.5 oz. (14.17 g)℮ PRINCIPAL DISPLAY PANEL - 14.17 g Stick Label

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 Distributed by Unconditional Love DBA Hello Bello, Los Angeles, CA 90272

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? (888) 860-6888

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.
WARNING For external use only. When using this product 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. For ages 2 and up. Keep out of reach of children.

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