ULTRA REPAIR- shea butter cream

ULTRA REPAIR by

Drug Labeling and Warnings

ULTRA REPAIR by is a Otc medication manufactured, distributed, or labeled by ULAB, U-LAB Switzerland AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: SHEA BUTTER 4.0%

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

Purpose: Moisturizing and soothing sensitized skin

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: Apply morning and night

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear.

DOSAGE & ADMINISTRATION

Dosage & Administration: Apply morning and night to face and neck after serum and ampoule

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA REPAIR 
shea butter cream

Product 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)