ORALABS CHAPICE ORIGINAL PETROLATUM- petrolatum stick

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

OraLabs

Via de administração:

TOPICAL

Tipo de prescrição:

OTC DRUG

Indicações terapêuticas:

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

Status de autorização:

OTC monograph final

Características técnicas

ORALABS CHAPICE ORIGINAL PETROLATUM- PETROLATUM STICK
ORALABS
_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
ORALABS CHAPICE ORIGINAL PETROLATUM
petrolatum stick
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63645-169
OraLabs
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
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:63645-169-
06
1 g in 1 CONTAINER; Type 0: Not a Combination
Product
03/09/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part347
03/09/2020
LABELER -
O