OTC Medication Information: A and D Original

A AND D ORIGINAL- lanolin and petrolatum ointment
Bayer HealthCare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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 — 4.25g Carton

NEW LOOK

A+D®

PREVENT

ORIGINAL

OINTMENT

Diaper Rash Ointment

+ Skin Protectant

Helps prevent &

treat diaper rash

Instantly forms a

protective barrier to

help seal out wetness

PEDIATRICIAN RECOMMENDED

PARABEN-FREE

DYE-FREE

PHTHALATE-FREE

NET WT

1.5 OZ (42.5g)

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANOLIN (LANOLIN) LANOLIN 136.4 mg in 1 g PETROLATUM (PETROLATUM) PETROLATUM 469.9 mg in 1 g

Inactive Ingredients Ingredient Name Strength COD LIVER OIL LIGHT MINERAL OIL MICROCRYSTALLINE WAX PARAFFIN

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:11523-0096-2 1 TUBE in 1 CARTON contains a TUBE 1 113 g in 1 TUBE This package is contained within the CARTON (11523-0096-2) 2 NDC:11523-0096-4 1 TUBE in 1 CARTON contains a TUBE 2 85 g in 1 TUBE This package is contained within the CARTON (11523-0096-4) 3 NDC:11523-0096-1 1 TUBE in 1 CARTON contains a TUBE 3 42.5 g in 1 TUBE This package is contained within the CARTON (11523-0096-1) 4 NDC:11523-0096-5 1 TUBE in 1 CARTON contains a TUBE 4 14 g in 1 TUBE This package is contained within the CARTON (11523-0096-5) 5 NDC:11523-0096-6 4 TUBE in 1 CARTON contains a TUBE 5 113 g in 1 TUBE This package is contained within the CARTON (11523-0096-6)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/04/2003

Labeler — Bayer HealthCare LLC. (112117283)

Revised: 09/2023 Bayer HealthCare LLC.