Label: AC CONTROL SERUM- allantoin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70380-070-01 - Packager: MIGUHARA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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 February 18, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Lavandula angustifolia (Lavender) flower extract, Alcohol, Lavandula angustifolia (Lavender) extract, Rosmarinus officinalis (Rosemary) extract, Thymus vulgaris (Thyme) extract, Mentha arvensis leaf extract, Borago officinalis extract, Salvia officinalis (Sage) leaf extract, Jasminum officinale (Jasmine) extract, Anthemis nobilis flower extract, Eclipta prostrata extract, Rehmannia glutinosa root extract, Artemisia princeps leaf extract, Portulaca oleracea extract, Glycyrrhiza glabra (Licorice) root extract, Butylene glycol, Sodium hyaluronate, Lonicera japonica(Honeysuckle) flower extract, Zanthoxylum piperitum fruit extract, Pulsatilla koreana extract, Citrus paradisi(Grapefruit) fruit extract, Citrus aurantium dulcis(Orange) fruit extract, Citrus medica limonum(Lemon) fruit extract, Pyrus malus(Apple) fruit extract, Dimethyl sulfone, Glycosyl trehalose, Hydrogenated starch hydrolysate, Arginine, Carbomer, PEG-60 hydrogenated castor oil, Menthol, Disodium EDTA, Rosmarinus officinalis (Rosemary) leaf oil
- PURPOSE
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WARNINGS
Warnings:
1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight
- KEEP OUT OF REACH OF CHILDREN
- Usage
- Usage
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AC CONTROL SERUM
allantoin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70380-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.1 g in 50 mL Inactive Ingredients Ingredient Name Strength LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70380-070-01 50 mL in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/02/2016 Labeler - MIGUHARA (689204213) Registrant - MIGUHARA (689204213) Establishment Name Address ID/FEI Business Operations MIGUHARA 689204213 manufacture(70380-070)
