Label: ASTONEA- zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 77338-304-03, 77338-304-04, 77338-304-05 - Packager: ASTONEA LABS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated August 18, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
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Directions
■ for diaper rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak sumac ■ apply ointment liberally as often as needed
- Other Information
- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
ASTONEA
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77338-304-03 28.3 g in 1 TUBE; Type 0: Not a Combination Product 05/23/2013 2 NDC:77338-304-04 56.6 g in 1 TUBE; Type 0: Not a Combination Product 05/23/2013 3 NDC:77338-304-05 425 g in 1 JAR; Type 0: Not a Combination Product 05/23/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/23/2013 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)