ASTONEA A AND D WITH LANOLIN- lanolin, petrolatum ointment

ASTONEA A and D WITH LANOLIN by

Drug Labeling and Warnings

ASTONEA A and D WITH LANOLIN 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

Active ingredients	Purpose
Lanolin 15.5%	Skin Protectant
Petrolatum 53.4%	Skin Protectant

Uses

• helps treat and prevent diaper rash
• temporarily protects minor:
  • cuts
  • scrapes
  • burns
• temporarily protects and helps relieve chapped, chafed or cracked skin and lips
• protect chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

Do not use on

• deep or puncture wounds .
• animal bites
• serious burns .

When using this product

• do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• for skin protectant useapply as needed
• for diaper rash use:
  • 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

Other information

• store between 20°C to 25 °C ( 68° to 77°F)
• do not use if tube seal under cap is broken

Inactive Ingredients

cholecalciferol, light mineral oil, microcrystalline wax, paraffin, vitamin A palmitate

TheraCare A&D Ointment

INGREDIENTS AND APPEARANCE

ASTONEA A AND D WITH LANOLIN 
lanolin, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	15.5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	53.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-213-04	1 in 1 CARTON	09/01/2021
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	09/01/2021

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)