Label: NATUREPLEX DIAPER RASH- zinc oxide cream
- NDC Code(s): 67234-001-01
- Packager: Natureplex LLC
- 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 September 4, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL - 42.5 g Tube Box
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INGREDIENTS AND APPEARANCE
NATUREPLEX DIAPER RASH
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 400 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CETYL ALCOHOL (UNII: 936JST6JCN) COCOA BUTTER (UNII: 512OYT1CRR) STARCH, CORN (UNII: O8232NY3SJ) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-001-01 1 in 1 BOX 01/02/2005 1 42.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 01/02/2005 Labeler - Natureplex LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-001)