GRANULOTION SKIN PROTECTANT- petrolatum cream
Pure Source 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.

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GranuLotion SKIN PROTECTANT

Active Ingredient

Petrolatum 50.74%

Purpose

Skin Protectant

Uses:

Helps prevent, temporarily protects and helps relieve chapped, cracked skin and minor skin irritations.

Warnings

When using this product: Do not get into eyes.

For external use only.

Do not use on: * deep or puncture wounds * animal bites * serious burns.

In case of accidental ingestion contact a physician or poison control center immediately.

See a doctor if condition lasts more than 7 days.

Keep out of reach of children.

Directions:

Cleanse skin gently with mild cleanser. Pat dry or allow to air dry. Apply a layer of GranuLotion™ on external skin around the site as needed. Use a cotton tipped applicator for hard to reach areas. Repeat as needed to protect or soothe the skin or until the condition resolves.

Inactive Ingredients:

Aqua (Deionized Water), Zinc Oxide, Menthol, BHT, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Lanolin, Melaleuca Alternifolia (Tea Tree) Oil, Mineral Oil, PEG-100 Stearate, Polysorbate-20, Potassium Alum, Silver (Cl 77820), FDandC Blue 1

GranuLotion SKIN PROTECTANT 2oz/56.6g (65121-355-02)

GranuLotion1

GranuLotion2

GRANULOTION SKIN PROTECTANT
petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:65121-355
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (PETROLATUM)	PETROLATUM	50.74 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER
ZINC OXIDE
MENTHOL
BUTYLATED HYDROXYTOLUENE
GLYCERYL MONOSTEARATE
LICORICE
LANOLIN
TEA TREE OIL
MINERAL OIL
PEG-100 STEARATE
POLYSORBATE 20
POTASSIUM ALUM
SILVER
FD&C BLUE NO. 1

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65121-355-02	56.6 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/09/2013

Labeler - Pure Source Inc (969241041)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source Inc		969241041	manufacture(65121-355)

Revised: 10/2013

Document Id: db0d117d-d481-49dd-9115-b4fbe10a44bc

Set id: 9134efb6-0703-457b-b84a-d502190b37b9

Version: 1

Effective Time: 20131009

Pure Source Inc