Drug Facts

Active Ingredients

Zinc Oxide 25% w/w

Kaolin 14.5% w/w

Purpose

Skin Protectant

Use

Helps treat and prevent diaper rash.

Warnings

For external use only.

When using this product avoid all contact with eyes.

Stop use and ask and doctor if condition worsens or does not improve within 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 the Poison Control Center immediately.

Directions

Change wet and soiled diapers promptly.
Clean the diaper area and allow to dry.
Apply ointment liberally as often as necessary with each diaper change.

Other Information

Store at 20 - 25° C (68 - 77° F).
Do not use if safety seal is missing or broken.

Inactive Ingredients

Beeswax/Cera Alba, Caprylhydroxamic Acid, Caprylyl Glycol, Cetearyl Alcohol, Glycerin, Caprae Lac/Goat Milk, Mineral Oil, Fragrance (in Original formula only), Petrolatum, Polysorbate 60.

Additional information listing on other panels

Manufactured for:

Canus Goat's Milk Skin Care Products Inc.

Drummondville (Québec) CANADA J2A 0N2

(514) 738-8998

1 Sheila Drive, Tinton Falls, New Jersey USA 07724

(848) 300-2227

www.lilgoats.com

Finished product not tested on animals.

Canus

NPN 80067434

NDC 70498-1100-5

Li'l Goat's Petite Chèvre

Improved Formula

25% Zinc Oxide - 14.5% Kaolin Diaper Rash Ointment

Fragrance free

142g

5 oz

PDP-fragrancefree

Principal Display Panel

Canus

NPN 80067431

NDC 70498-1150-5

Li'l Goat's Petite Chèvre

Improved Formula

25% Zinc Oxide - 14.5% Kaolin Diaper Rash Ointment

Original

142g

5 oz

PDP-original

LIL GOATS PETITE CHEVRE ORIGINAL
zinc oxide and kaolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70498-1150
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO)	KAOLIN	145 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	250 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WHITE WAX (UNII: 7G1J5DA97F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
GOAT MILK (UNII: XE5K5I4RP7)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70498-1150-5	1 in 1 BOX	05/23/2016
1		142 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/23/2016

LIL GOATS PETITE CHEVRE FRAGRANCE FREE
zinc oxide and kaolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70498-1100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	250 mg in 1 g
KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO)	KAOLIN	145 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WHITE WAX (UNII: 7G1J5DA97F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
GOAT MILK (UNII: XE5K5I4RP7)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70498-1100-5	1 in 1 BOX	05/23/2016
1		142 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/23/2016

Labeler - Produits De Soins Pour La Peau Au Lait De Chevre Canus Inc (253084008)

Name	Address	ID/FEI	Business Operations
Establishment
KDC/ONE Development Corporation, Inc		204006464	manufacture(70498-1150, 70498-1100)