VITAMIN A AND D- lanolin, petrolatum ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)

Available from:

Trifecta Pharmaceuticals USA LLC

INN (International Name):

PETROLATUM

Composition:

PETROLATUM 53.4 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness Condition worsens Symptoms last more than 7 days or clear up and occur again with a few days

Authorization status:

OTC monograph final

Summary of Product characteristics

VITAMIN A AND D- LANOLIN, PETROLATUM OINTMENT
TRIFECTA PHARMACEUTICALS USA LLC
_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._
----------
VITAMIN A AND D OINTMENT
ACTIVE INGREDIENT
Lanolin 15.5%
Petrolatum 53.4%
PURPOSE
Skin Protectant
USES
Helps treat and prevent diaper rash
Protects chafed skin due to diaper rash and helps seal out wetness
STOP USE AND ASK A DOCTOR
Condition worsens
Symptoms last more than 7 days or clear up and occur again with a few
days
KEEP OUR OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
immediately
DIRECTIONS
Change wet and soiled diapers promptly
Cleanse the diaper area and allow to dry
Apply ointment liberally as often as necessary, with each diaper
change, especially at
bedtime or anytime when exposure to wet diapers may be prolonged.
INACTIVE INGREDIENTS
Cod liver oil (contains Vitamin A and Vitamin D), Fragrance, Mineral
Oil, Microcrystalline
Wax, Paraffin
DISTRIBUTED BY
TRIFECTA PHARMACEUTICALS USA
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301
Product of PRC
WWW.TRIFECTA-PHARMA.COM
WARNINGS
For external use only
When using this product avoid contact with eyes
Store at controlled room temperature 20º 25ºC (68º-77ºF)
Questions 1-888-296-9067
PACKAGING
VITAMIN A AND D
lanolin, petrolatum ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69396-009
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
PETROLATUM
53.4 g in 100 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)
LANOLIN
15.5 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)
COD LIVER OIL (UNII: BBL281NWFG)
MINERAL OIL (UNII: T5L8T28FGP)
Trifecta Pharmaceuticals USA LLC
PACKAGING
#
ITEM C