Leader Original SPF 4 Lip Balm: Package Insert and Label Information

LEADER ORIGINAL SPF 4 LIP BALM- petrolatum and padimate o stick
Cardinal Health (Leader)

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.

Active ingredient

Padimate O, Petrolatum

Purpose

Sunscreen, Skin Protectant

Keep Out of Reach of Children

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

Uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only

Stop use and ask a doctor: If rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed.

Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Mineral Oil, Ozokerite, Microcrystalline Wax, Phenyl Trimethicone, Lanolin, Copercicia (Carnauba) Wax, Isopropyl Myristate, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Flavor, Camphor, Methylparaben, Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 6 Lake (CI 15850).

Package/Label Principal Display Panel

LEADER ORIGINAL SPF 4 LIP BALM padimate o, petrolatum stick

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-694 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (PETROLATUM) PETROLATUM 44.0 mg in 1 g PADIMATE O (PADIMATE O) PADIMATE O 1.5 mg in 1 g

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE WAX 3.00 mg in 1 g LANOLIN 1 mg in 1 g CERESIN 17.30 mg in 1 g CARNAUBA WAX 1 mg in 1 g ISOPROPYL MYRISTATE 2.23 mg in 1 g LIGHT MINERAL OIL 27.50 mg in 1 g

Product Characteristics Color PINK Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:37205-694-03 1 g in 1 CONTAINER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/15/2013

Labeler — Cardinal Health (Leader) (097537435)

Registrant — Cardinal Health (Leader) (097537435)

Establishment
Name	Address	ID/FEI	Operations
OraLabs		801824756	MANUFACTURE (37205-694), LABEL (37205-694)

Revised: 04/2014 Cardinal Health (Leader)