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

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Cardinal Health (Leader)

INN (שם בינלאומי):

PETROLATUM

הרכב:

PETROLATUM 44.0 mg in 1 g

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

OTC DRUG

סממני תרפויטית:

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

מצב אישור:

OTC monograph not final

מאפייני מוצר

LEADER ORIGINAL SPF 4 LIP BALM- PADIMATE O, PETROLATUM 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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Padimate O, Petrolatum
PURPOS E
Sunscreen, Skin Protectant
KEEP OUT OF REACH OF CHILDREN
If swallowed get medical help or contact a Poison Control Center right
away.
US ES
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 T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:3720 5-6 9 4
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)
PETROLATUM
44.0 mg in 1 g
PADIMATE O (UNII: Z110 0 6 CMUZ) (PADIMATE O - UNII:Z110 0 6 CMUZ)
PADIMATE O
1.5 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)
3.0 0 mg in 1 g
LANO LIN (UNII: 7EV6 5EAW6 H)
1 mg in 1 g
CERESIN (UNII: Q1LS2UJO3A)
17.30 mg in 1 g
CARNAUBA WAX (UNII: R12CBM0 EIZ)
1 mg in 1 g
ISO PRO PY