Label: A AND D PLUS E- vitamin a, d, and e ointment ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 61554-200-01, 61554-200-02, 61554-200-03, 61554-200-04, view more61554-200-05, 61554-200-06 - Packager: Gentell, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 November 6, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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 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.
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
- INSTRUCTIONS FOR USE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
A AND D PLUS E
vitamin a, d, and e ointment ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61554-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 0.9985 g in 1 g Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) VITAMIN D (UNII: 9VU1KI44GP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61554-200-01 56.7 g in 1 TUBE; Type 0: Not a Combination Product 11/03/2014 2 NDC:61554-200-02 113.4 g in 1 TUBE; Type 0: Not a Combination Product 11/03/2014 3 NDC:61554-200-03 368.5 g in 1 JAR; Type 0: Not a Combination Product 11/03/2014 4 NDC:61554-200-04 453.6 g in 1 JAR; Type 0: Not a Combination Product 11/03/2014 5 NDC:61554-200-05 567 g in 1 JAR; Type 0: Not a Combination Product 11/03/2014 6 NDC:61554-200-06 5 g in 1 PACKET; Type 0: Not a Combination Product 11/03/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 11/03/2014 Labeler - Gentell, Inc. (170967876) Establishment Name Address ID/FEI Business Operations Gentell, Inc. 170967876 manufacture(61554-200)