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Baby bum hand sanitizer - Medication Information

Product NDC Code 69039-614
Drug Name

Baby bum hand sanitizer

Type Brand
Active Ingredients
Alcohol .62 ml/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 247835
Application Number part333E
Labeler Name Sun Bum LLC
Packages
Package NDC Code Description
69039-614-01 59 ml in 1 bottle, spray (69039-614-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Ethyl alcohol 62% Purpose Antiseptic

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 spray enough product in your palms to thoroughly cover your hands rub hands together briskly until dry children under 6 years of age should be supervised when using this product

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water,fragrance,glycerin,aloe barbadensis leaf juice, cucumis sativus (cucumber) fruit extract, musa sapientum (banana) fruit extract, hedychium coronarium root extract, gardenia taitensis flower extract, cocos nucifera (coconut) oil, sea salt, ethylhexylglycerin

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 to help reduce bacteria on the skin recommended for repeated use

Purpose

Information about the drug product’s indications for use.
Purpose Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
Baby Bum Hand Sanitizer ALCOHOL WATER GLYCERIN ALOE VERA LEAF CUCUMBER BANANA HEDYCHIUM CORONARIUM ROOT GARDENIA TAITENSIS FLOWER COCONUT OIL SEA SALT ETHYLHEXYLGLYCERIN ALCOHOL ALCOHOL

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.
Package Labeling: Bottle4

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 Other information do not store above 104° F/40°C may discolor some fabrics or surfaces

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? 1-877-978-6286

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 irritation or rash appears and lasts. Condition persists for more than 72 hours

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 use in or near the eyes. In case of eye contact, rinse thoroughly with water.

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 Flammable keep away from fire or flame When using this product do not use in or near the eyes. In case of eye contact, rinse thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts. Condition persists for more than 72 hours Keep out of reach of children. If 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