Active ingredient A list of the active, medicinal ingredients in the drug product.
Active Ingredients Kaolin 4.0%
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 ▪ Change wet and soiled diapers promptly ▪ Cleanse the diaper area ▪ Allow to dry ▪ apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.
Inactive ingredient A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Carnauba Wax, Tocopherol, Acmella Oleracea, Olea Europaea (Olive) Oil*, Chamomile Oil*, Jojoba Esters, Calendula Officinalis Extract*, Avena Sativa (Oat) Kernel Flour*, Helianthus Annuus (Sunflower) Seed Oil*, Candelilla Wax, Shea Butter*. *Certified Organic.
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 diaper rash ▪ Protects chafed skin (or minor skin irritation) due to diaper rash ▪ Helps protect from wetness that causes diaper rash ▪ Temporarily helps relieve minor skin irritation due to diaper rash.
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.
DRUIDE BIOLOVE FOR DIAPER RASH KAOLIN HELIANTHUS ANNUUS FLOWERING TOP CARNAUBA WAX AVENA SATIVA TOP OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES HYDROLYZED JOJOBA ESTERS (ACID FORM) TOCOPHEROL ACMELLA OLERACEA FLOWERING TOP SHEA BUTTER CHAMOMILE FLOWER OIL KAOLIN KAOLIN CANDELILLA WAX CALENDULA OFFICINALIS SEED 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.
DRUIDE BIOLOVE PASTE FOR DIAPER RASH 60 G (NDC 71447-300-00) Druide Bio Love Diaper Rash Paste 60g
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.
Other Information Keep in a cool place to prevent the paste from melting.
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 damaged or broken skin.
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 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 or Comments? 1-800-263-8888 Outside Canada or the United States dial 514-333-8282 or visit www.druidebio.com
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.
When using this product keep out of 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