DRUIDE BIOLOVE FOR DIAPER RASH: Package Insert and Label Information

DRUIDE BIOLOVE FOR DIAPER RASH- kaolin paste
LABORATOIRES DRUIDE INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active Ingredients

Kaolin 4.0%

Purpose

Skin Protectant

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.

Warnings

For external use only

Do not use

on damaged or broken skin.

When using this product

keep out of 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.

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

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.

Other Information

Keep in a cool place to prevent the paste from melting.

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.

Questions or Comments?

1-800-263-8888
Outside Canada or the United States dial 514-333-8282 or visit www.druidebio.com

DRUIDE BIOLOVE PASTE FOR DIAPER RASH 60 G (NDC 71447-300-00)

DRUIDE BIOLOVE FOR DIAPER RASH kaolin paste

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71447-300 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KAOLIN (KAOLIN) KAOLIN 4 g in 100 g

Inactive Ingredients Ingredient Name Strength CANDELILLA WAX CALENDULA OFFICINALIS SEED OIL AVENA SATIVA TOP HELIANTHUS ANNUUS FLOWERING TOP CARNAUBA WAX OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES HYDROLYZED JOJOBA ESTERS (ACID FORM) TOCOPHEROL ACMELLA OLERACEA FLOWERING TOP SHEA BUTTER CHAMOMILE FLOWER OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71447-300-01 1 TUBE in 1 BOX contains a TUBE (71447-300-00) 1 NDC:71447-300-00 100 g in 1 TUBE This package is contained within the BOX (71447-300-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/16/2019

Labeler — LABORATOIRES DRUIDE INC (245815014)

Registrant — LABORATOIRES DRUIDE INC (245815014)

Establishment
Name	Address	ID/FEI	Operations
EUROPE SKIN CARE AVENUE CORP		117190623	pack (71447-300)

Establishment
Name	Address	ID/FEI	Operations
7774672 CANADA INC		203095039	pack (71447-300)

Establishment
Name	Address	ID/FEI	Operations
LABORATOIRES DRUIDE INC		245815014	manufacture (71447-300)

Revised: 12/2019 LABORATOIRES DRUIDE INC