Label: ULTRA REPAIR- shea butter cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 71276-090-01, 71276-090-02 - Packager: ULAB
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated March 22, 2017
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
Inactive ingredients: Aqua (WATER), CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOHEXADECANE, PEG-8 BEESWAX, MARIS AQUA (SEA WATER), MACADAMIA INTEGRIFOLIA SEED OIL, CETYL ALCOHOL, POLYACRYLAMIDE, PROPYLENE GLYCOL DIPELARGONATE, PHENOXYETHANOL, GLYCERYL STEARATE, PROPANEDIOL, C13-14 ISOPARAFFIN, HYDROXYACETOPHENONE, THEOBROMA GRANDIFLORUM SEED BUTTER, PROPYLENE GLYCOL, CETETH-20, TOCOPHERYL ACETATE, STEARETH-20, CENTELLA ASIATICA EXTRACT, LAURETH-7, GLYCERIN, PARFUM (FRAGRANCE), TOCOPHEROL, NYMPHAEA ALBA FLOWER EXTRACT, POTASSIUM SORBATE, CITRIC ACID, TROPOLONE, GARDENIA TAHITENSIS FLOWER EXTRACT, CUCURBITA PEPO (PUMPKIN) SEED EXTRACT, SODIUM HYDROXIDE, SODIUM BENZOATE
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ULTRA REPAIR
shea butter creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71276-090 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER 2.4 g in 60 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71276-090-02 1 in 1 CARTON 03/02/2017 1 NDC:71276-090-01 60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/02/2017 Labeler - ULAB (688976692) Registrant - ULAB (688976692) Establishment Name Address ID/FEI Business Operations ULAB 688976692 relabel(71276-090) Establishment Name Address ID/FEI Business Operations U-LAB Switzerland AG 485958743 manufacture(71276-090)