THERACARE VITAMIN A AND D PLUS E- petrolatum ointment

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Petrolatum 99.85%

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 (1-800-222-1222) right away.

Directions

• for skin protectant use apply 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

alpha-tocopherol acetate (vitamin E), cholecalciferol (vitamin D3), medium chain triglycerides USP, retinyl palmitate(vitamin A palmitate)

TheraCare Vitamin A&D + E Ointment

INGREDIENTS AND APPEARANCE

THERACARE VITAMIN A AND D PLUS E 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.85 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-109-13	368 g in 1 JAR; Type 0: Not a Combination Product	05/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	05/01/2026

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Dabur India Limited		650599231	manufacture(71101-109)