A And D Original (Lanolin And Petrolatum) Ointment [Bayer Healthcare Llc.] -

A AND D ORIGINAL (LANOLIN AND PETROLATUM) OINTMENT [BAYER HEALTHCARE LLC.]
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NDC	11523-0096-1, 11523-0096-2, 11523-0096-4
Set ID	aceb23f8-a431-415c-aefd-97047e1aac03
Category	HUMAN OTC DRUG LABEL
Packager	Bayer HealthCare LLC.
Generic Name
Product Class
Product Number
Application Number	PART347

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SPL UNCLASSIFIED SECTION

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

Active ingredients Purpose
Lanolin 15.5% Diaper rash ointment
Petrolatum 53.4% Skin Protectant

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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
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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.

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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
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Other information

store between 20°C to 25 °C (68° to 77°F)
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Inactive Ingredients

cod liver oil ( contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin
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PRINCIPAL DISPLAY PANEL - 85 g Carton
PEDIATRICIAN

RECOMMENDED

A+D®

Prevent

Original

Ointment

DIAPER RASH OINTMENT

& SKIN PROTECTANT
- Helps prevent &
  
  treat diaper rash
- Forms a protective
  
  barrier to help
  
  seal out wetness
NET WT 3 OZ (85g)

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Active ingredients	Purpose
Lanolin 15.5%	Diaper rash ointment
Petrolatum 53.4%	Skin Protectant

INGREDIENTS AND APPEARANCE

A AND D ORIGINAL
lanolin and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-0096
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11523-0096-2	1 in 1 CARTON	06/04/2004
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11523-0096-4	1 in 1 CARTON	06/04/2003
2		85 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:11523-0096-1	1 in 1 CARTON	06/04/2003
3		42.5 g in 1 TUBE; Type 0: Not a Combination Product