Label: TENA- zinc oxide protective cream lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 59608-003-05, 59608-003-10 - Packager: SCA Personal Care 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 July 18, 2017
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
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients: Acacia Decurrens Flower Wax, Caprylic/Capric Triglyceride, Citric Acid, Dicaprylyl Carbonate,
Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Wax, Jojoba Esters, Magnesium Sulfate, PEG-8 Beeswax, Polyglycerin-3,
Polyglyceryl-3 Ricinoleate, Potassium Sorbate, Sodium Benzoate, Sodium Citrate, Sodium Gluconate, Sorbitan Caprylate, Sorbitan
Isostearate, Tocopherol, Vegetable Oil, Water.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TENA
zinc oxide protective cream lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59608-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10 g in 100 mL Inactive Ingredients Ingredient Name Strength ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) YELLOW WAX (UNII: 2ZA36H0S2V) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM GLUCONATE (UNII: R6Q3791S76) SORBITAN (UNII: 6O92ICV9RU) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) TOCOPHEROL (UNII: R0ZB2556P8) CORN OIL (UNII: 8470G57WFM) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59608-003-10 100 mL in 1 TUBE; Type 0: Not a Combination Product 06/07/2017 2 NDC:59608-003-05 5 mL in 1 TUBE; Type 0: Not a Combination Product 06/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/07/2017 Labeler - SCA Personal Care Inc. (790100549)
