ASTONEA-VITAMINS A AND D- petrolatum ointment

ASTONEA-Vitamins A and D by

Drug Labeling and Warnings

ASTONEA-Vitamins A and D by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

White Petrolatum USP (93.4%w/w)

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash
• Helps seal out wetness
• Temporarily protects minor
  • cuts
  • scrapes
  • burns
• Temporarily helps protect and relieve chapped and cracked skin or lips
• Helps prevent and protect from the drying effects of wind and cold weather
• Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
• With each diaper change, especially at bedtime when exposure to wetness may be prolonged

Warnings

For external use only

When using this product

• Do not get into eyes

Stop Use and consult a doctor if

• condition worsens
• symptoms last more than 7 days
• symptoms clear up and reoccur in a few days

Do not use on

• deep puncture wounds
• animal bites
• serious burns

Keep out of reach of children! If swallowed, get medical help or contact a Poison Control Center immediately

Directions for use with Diaper Rash

• change wet and soiled diaper promptly
• cleanse the diaper area and allow to dry
• apply as needed

Other information

• store at 15°-30°C (59°-86°F)
• avoid excessive heat and humidity

Inactive Ingredients

• Lanolin, Paraffin, Light Mineral Oil, Vitamin A, Vitamin D, CI 12740

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASTONEA-VITAMINS A AND D 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	0.934 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SOLVENT YELLOW 18 (UNII: L4SQI4K87S)
LANOLIN (UNII: 7EV65EAW6H)
PARAFFIN (UNII: I9O0E3H2ZE)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
VITAMIN A (UNII: 81G40H8B0T)
VITAMIN D (UNII: 9VU1KI44GP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-105-32	5 g in 1 PACKET; Type 0: Not a Combination Product	05/02/2022
2	NDC: 77338-105-33	113 g in 1 TUBE; Type 0: Not a Combination Product	05/02/2022
3	NDC: 77338-105-35	425 g in 1 JAR; Type 0: Not a Combination Product	05/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/02/2022

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Establishment
Name	Address	ID/FEI	Business Operations
ASTONEA LABS PRIVATE LIMITED		878533295	manufacture(77338-105)