Label: ALOE SOOTHING- glycerin gel
- Category: HUMAN OTC DRUG LABEL
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.
Updated February 18, 2016
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- ACTIVE 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.
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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70380-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin 16.0 g in 200 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70380-080-01 200 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(70380-080)