ALOE SOOTHING- glycerin gel 
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: Glycerin 8.0%

INACTIVE INGREDIENT

Inactive Ingredients: Aloe vera leaves, lactobacillus/ filtered Aloe vera fermentation, Butylene Glycol, Betaine, Piper Methysticum Leaf/Root/Stem Extract, Hydroxyethylcellulose, Carbomer, arginine, a longleaf pine extract, a shaddock seed extract, bambusa textilis stem extract, PEG-60 Hydrogenated Castor Oil, Aspalathus Linearis Leaf Ferment Extract, Sodium Hyaluronate, green tea catechin, flavouring.

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: Take an appropriate amount and gently apply it on the face.

Usage

Usage: Take an appropriate amount and gently apply it on the face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ALOE SOOTHING 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70380-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin16.0 g  in 200 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70380-080-01200 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(70380-080)

Revised: 2/2016
Document Id: 2cda78b6-439f-4281-8d3c-a035c546c4a2
Set id: 58b32354-376e-4c12-b9b7-719ec65038fd
Version: 1
Effective Time: 20160218
 
MIGUHARA