DIAPER RASH SKIN PROTECTANT- lanolin and petrolatum ointment

Diaper Rash skin protectant by

Drug Labeling and Warnings

Diaper Rash skin protectant by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Centre LLC, Anicare Pharmaceuticals Pvt. Ltd, Anicare Pharmaceutical Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

ACTIVE INGREDIENT

Active ingredients	Purpose
Lanolin 15.5%	Diaper rash ointment
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

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

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

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

Inactive Ingredients

cod liver oil ( contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

PRINCIPAL DISPLAY PANEL - 35.4g Carton

INGREDIENTS AND APPEARANCE

DIAPER RASH SKIN PROTECTANT 
lanolin and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	136.4 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	469.9 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COD LIVER OIL (UNII: BBL281NWFG)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)

Product Characteristics
Color	orange (Unctuous amber mass)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-073-02	1 in 1 CARTON	01/25/2021
1	NDC: 52000-073-01	35.4 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 final	part347	01/25/2021

Labeler - Universal Distribution Centre LLC (019180459)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceutical Pvt. Ltd		916837425	manufacture(52000-073)