Label: LINCOLN- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69636-3066-4 - Packager: Lincoln Pharmaceuticals Ltd.
- 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 10, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender, methyl paraben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium, steareth-20, trolamine, vitamin A, water, FD&C Yellow No. 5, D&C Red No. 21
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
LINCOLN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69636-3066 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.8 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) LANOLIN (UNII: 7EV65EAW6H) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) STEARETH-20 (UNII: L0Q8IK9E08) CETETH-10 (UNII: LF9X1PN3XJ) PETROLATUM (UNII: 4T6H12BN9U) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 60 (UNII: CAL22UVI4M) TROLAMINE (UNII: 9O3K93S3TK) VITAMIN A (UNII: 81G40H8B0T) WATER (UNII: 059QF0KO0R) D&C RED NO. 21 (UNII: 08744Z6JNY) GLYCERIN (UNII: PDC6A3C0OX) LAVENDER OIL (UNII: ZBP1YXW0H8) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) CHOLECALCIFEROL (UNII: 1C6V77QF41) PHENOXYETHANOL (UNII: HIE492ZZ3T) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69636-3066-4 99.2 g in 1 TUBE; Type 0: Not a Combination Product 01/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/10/2017 Labeler - Lincoln Pharmaceuticals Ltd. (915839373)