Label: ENDIT ZINC OXIDE SKIN PROTECTANT- zinc oxide ointment
- NDC Code(s): 64068-402-01
- Packager: Endit Laboratories, 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 January 29, 2021
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- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose:
- Uses:
- Warnings:
- KEEP OUT OF REACH OF CHILDREN
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Directions:
- Change wet and soiled diapers promptly.
- Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry.
- Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled dapers (feces, and/or urine) may be prolonged.
- Other Ingredients:
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
ENDIT ZINC OXIDE SKIN PROTECTANT
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64068-402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 g in 100 g Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) FERRIC OXIDE RED (UNII: 1K09F3G675) STARCH, CORN (UNII: O8232NY3SJ) JUNIPER TAR (UNII: 1Q84T0P2G3) LANOLIN (UNII: 7EV65EAW6H) RESORCINOL (UNII: YUL4LO94HK) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64068-402-01 454 g in 1 JAR; Type 0: Not a Combination Product 05/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/31/2017 Labeler - Endit Laboratories, Inc. (065285207) Establishment Name Address ID/FEI Business Operations Kalchem International Inc. 805294014 manufacture(64068-402) , label(64068-402) , pack(64068-402)