Vitamins A and D Rash: Package Insert and Label Information

VITAMINS A AND D RASH- lanolin and petrolatum ointment
Rite Aid

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.

Active ingredients

Lanolin 15.5%

Petrolatum 53.4%

Purpose

Skin protectant

Uses

  • helps treat and prevent diaper rash
  • temporarily protects minor: cuts, scrapes, burns
  • temporarily protects and relieves chapped, chafed or cracked skin and lips
  • helps protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

  • avoid contact with eyes. If contact occurs, rinse with water.

Stop using this product and ask doctor if

  • condition worsens
  • symptoms last for 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.
  • In case of accidental ingestions, get medical help or contact a Poison Control Center immediately.

Directions

  • for skin protectant use and apply as needed
  • for diaper rash use: change wet and soiled diapers promptly. Clean the diaper area, and allow to dry. Apply ointment as often as required, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive ingredients

Cod Liver Oil, Fragrance (Parfum), Mineral Oil, Microcrystalline Wax, Paraffin.

Questions/Comments

1-866-695-3030

Other information

store between 20°C — 25°C (68°F — 77°F)

Label Copy

Image of the description
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VITAMINS A AND D RASH
lanolin and petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-3402
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANOLIN (LANOLIN) LANOLIN 15.5 g in 100 g
PETROLATUM (PETROLATUM) PETROLATUM 53.4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
COD LIVER OIL
MINERAL OIL
MICROCRYSTALLINE WAX
PARAFFIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-3402-1 454 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 08/13/2019
Labeler — Rite Aid (014578892)
Registrant — Apollo Health and Beauty Care Inc. (201902109)
Establishment
Name Address ID/FEI Operations
Apollo Health and Beauty Care Inc. 201901209 manufacture (11822-3402)

Revised: 08/2019 Rite Aid

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