WINCO ORIGINAL PETROLATUM- petrolatum stick

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)

זמין מ:

Winco

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

OTC DRUG

סממני תרפויטית:

Skin Protectant Helps prevent and temporarily protect dry, chapped or windburned lips.

מצב אישור:

OTC monograph final

מאפייני מוצר

WINCO ORIGINAL PETROLATUM- 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
Petrolatum, 45%
PURPOSE
Skin Protectant
KEEP OUT OF REACH OF CHILDREN
If swallowed get medical help or contact a Poison Control Center right
away.
USES
Helps prevent and temporarily protect dry, chapped or windburned lips.
WARNINGS
For external use only. Stop use and ask a doctor if rash or irritation
develops and lasts.
Children under 6 months of age: Ask a doctor before use.
DIRECTIONS
Apply as needed.
INACTIVE INGREDIENTS
Camphor, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia
Cerifera
(Candelilla) Wax, Flavor, Isopropyl Myristate, Lanolin,
Microcrystalline Wax, Mineral Oil,
Ozokerite, Phenyl Trimethicone, Red 6 Lake (CI 15850), Titanium
Dioxide (CI 77891),
Yellow 5 Lake (CI 19140).
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
WINCO ORIGINAL PETROLATUM
petrolatum stick
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:67091-253
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
PETROLATUM
45 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
LIGHT MINERAL OIL (UNII: N6K5787QVP)
28 ug in 1 g
WHITE WAX (UNII: 7G1J5DA97F)
17.5 mg in 1 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
3.0 mg in 1 g
LANOLIN (UNII: 7EV65EAW6H)
1.0 mg in 1 g
PRODUCT CHARACTERISTICS
COLOR
PINK
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
Winco
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:67091-253-
01
1 g in 1 CONTAINER; Type 0: Not a Combination
Product
06/15/2023
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part347
06/15/2023
LABELER -
Winco (056098817)
REGISTR