OTC Medication Information: U-max Whitening Functional Essence

U-MAX WHITENING FUNCTIONAL ESSENCE — allantoin cream
VS Shinbi Co., Ltd.

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.

active ingredient: allantoin
inactive ingredient: water, glycerin, propylene glycol, arbutin, disodium EDTA, tocopheryl acetate, carbomer, caprylic triglyceride, petrolatum, stearic acid, cetearyl alcohol, glyceryl stearate, sorbitan stearate, houttuynia cordata extract, saururus chinensis extract, xanthium strumarium fruit extract, solanum lycopersicum fruit extract, eclipta prostrata leaf extract, angelica gigas root extract, glycyrrhiza glabra root extract, camellia sinensis leaf extract, hydrolyzed soybean extract, artemisia vulgaris extract, perfume, portulaca oleracea extract, salicornia herbacea extract, laminaria japonica extract, taraxacum officinale leaf extract, morus bombycis leaf extract, poria cocos extract, eucommia ulmoides leaf extract, citrus paradisi seed oil, ubiquinone, biosaccharide gum-1, hydroxypropyl methylcellulose, iron titanium oxide, cellulose
skin whitening
keep out of reach of the children
– apply only for skin
– apply 2 or 3 times a day with 5~6ml
– massage with your finger over 2 min and let them dry
– keep out of eyes, ears and mouth
– if contact occurs, rinse away with plenty of cold water
– for external use only
package label
(click image for full-size original)
U-MAX WHITENING FUNCTIONAL ESSENCE
allantoin cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50795-3001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLANTOIN (ALLANTOIN) ALLANTOIN 0.1 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
HOUTTUYNIA CORDATA FLOWERING TOP
XANTHIUM STRUMARIUM FRUIT
SOLANUM LYCOPERSICUM
ANGELICA GIGAS ROOT
GLYCYRRHIZA GLABRA
ARTEMISIA VULGARIS ROOT
ARBUTIN
.ALPHA.-TOCOPHEROL ACETATE
MINERAL OIL
STEARIC ACID
CETOSTEARYL ALCOHOL
LAMINARIA JAPONICA
TARAXACUM OFFICINALE
CITRUS PARADISI SEED
GLYCERYL MONOSTEARATE
SORBITAN SESQUIOLEATE
GREEN TEA LEAF
PORTULACA OLERACEA WHOLE
SALICORNIA EUROPAEA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50795-3001-1 120 mL in 1 BOTTLE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/04/2012
Labeler — VS Shinbi Co., Ltd. (557817055)
Registrant — VS Shinbi Co., Ltd. (557817055)
Establishment
Name Address ID/FEI Operations
VS Shinbi Co., Ltd. 557817055 manufacture

Revised: 06/2012 VS Shinbi Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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