DRUIDE BIOLOVE FOR DIAPER RASH- kaolin paste

DRUIDE BIOLOVE FOR DIAPER RASH by

Drug Labeling and Warnings

DRUIDE BIOLOVE FOR DIAPER RASH by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES DRUIDE INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

DRUIDE BIOLOVE FOR DIAPER RASH 
kaolin paste

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO)	KAOLIN	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CANDELILLA WAX (UNII: WL0328HX19)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
AVENA SATIVA TOP (UNII: 1ZX4OXU3N6)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
TOCOPHEROL (UNII: R0ZB2556P8)
ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53)
SHEA BUTTER (UNII: K49155WL9Y)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71447-300-01	1 in 1 BOX	12/16/2019
1	NDC: 71447-300-00	100 g in 1 TUBE; Type 0: Not a Combination Product

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	Business Operations
EUROPE SKIN CARE AVENUE CORP		117190623	pack(71447-300)

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

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