LIL GOATS ZINC OXIDE- zinc oxide cream 
Canus Vermont LLC

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.

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Lil Goats Diaper Rash Ointment

Active Ingredients:

Petrolatum

Zinc Oxide

Purpose:

Skin Protectant.

Use:

Helps treat and prevent diaper rash

WARNING:

For external use only.

When using this product,

avoid all contact with eyes.

Stop use and ask a doctor:

if condition worsens or does not improve within 7 days.

Keep out of reach of children.

If swallowed:

get medical help or contact the Poison Control Center immediately.

Directions:

Apply oitment literally as often as necessary with each diaper change.

Change wet and soiled diapers promptly.

Clean the diaper area and allow to dry.

Store:

at 20-25°C (68-77°F)

Inactive Ingredients:

Caprae Lac, Meneral Oil, Emulsifying Wax NF, Beeswax, Parfum, Propylene Glycol, Dizolidinyl Urea, Methylparaben, Propylparaben.

Manufactured by:

LEK Packaging Inc.

Knowlton, Qc, Canada

For:

Canus Goats Milk Skin Care Products Inc.

Les produits de soins pour la peru au lait de chèvre Canus inc.

Questions:

Tel: (514)-738-8998, Ville St-Laurent, Qc, Canada

Tel: (802) 244-4628, Waterbury USA, 05676

Other information:

Not tested on animals.

142g/5oz

wrap label and CartonZOcdn5oz

LIL GOATS ZINC OXIDE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10100-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 142 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM49.5 g  in 142 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP) 2.5 g  in 142 g
GOAT MILK (UNII: XE5K5I4RP7) 5 g  in 142 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10100-119-021 in 1 CARTON
1NDC:10100-119-01142 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2013
Labeler - Canus Vermont LLC (102493025)
Establishment
NameAddressID/FEIBusiness Operations
Les Emballages Knowlton Inc.248704645manufacture(10100-119) , analysis(10100-119)

Revised: 2/2013
Document Id: d49d434c-73fe-42d8-9b06-a3bec3457e5c
Set id: d3c61351-d7f2-4afe-b993-19077f596480
Version: 1
Effective Time: 20130206
 
Canus Vermont LLC