WINCO ORIGINAL SPF 4 LIP BALM- padimate o, petrolatum stick

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)

Available from:

Winco

INN (International Name):

PETROLATUM

Composition:

PETROLATUM 44.0 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

WINCO ORIGINAL SPF 4 LIP BALM- PADIMATE O, PETROLATUM STICK
WINCO
_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._
----------
DRUG FACTS
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
Do not use on damaged or broken skin
Stop use and ask a doctor: If rash or irritation develops and lasts
for more than 7 days.
When using this product keep out of eyes. Rinse with water to remove.
Keep out of reach of children: If swallowed get medical help or
contact a Poison Control
Center right away.
DIRECTIONS
Apply liberally 15 minutes before sun exposure. Reapply as needed.
Children under 6 months of age: Ask a doctor before use.
INACTIVE INGREDIENTS
Mineral Oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl
Myristate, Phenyl
Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia
Cerifera
(Candelilla) Wax, Cetyl Alcohol, Red 6 Lake (CI 15850), Yellow 5 Lake
(CI 19140),
Methylparaben
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
WINCO ORIGINAL SPF 4 LIP BALM
padimate o, petrolatum stick
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:67091-249
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
PETROLATUM
44.0 mg in 1 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)
PADIMATE O
1.5 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
LIGHT MINERAL OIL