AC CONTROL SERUM- allantoin cream 
MIGUHARA

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.

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ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.2%

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

Purpose: Skin Protectant

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

KEEP OUT OF REACH OF CHILDREN

Usage

Usage: An appropriate amount and evenly apply it on the face along the skin texture.

Usage

Usage: An appropriate amount and evenly apply it on the face along the skin texture.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AC CONTROL SERUM 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70380-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.1 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70380-070-0150 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/02/2016
Labeler - MIGUHARA (689204213)
Registrant - MIGUHARA (689204213)
Establishment
NameAddressID/FEIBusiness Operations
MIGUHARA689204213manufacture(70380-070)

Revised: 2/2016
Document Id: 7898579a-57a4-45d2-9a52-127cd6a4f487
Set id: 7bd6ae6a-5414-4595-a986-7dfccfd01572
Version: 1
Effective Time: 20160218
 
MIGUHARA