Label: ALOE PROPOLIS SOOTHING- allantoin gel
- NDC Code(s): 69998-100-01, 69998-100-02
- Packager: BENTON KOREA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated August 16, 2016
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- ACTIVE INGREDIENT
Inactive Ingredients: Aloe Barbadensis Leaf Juice, Propolis Extract, Glycerin, Pentylene Glycol, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Betaine, Arginine, Cucumis Sativus (Cucumber) Fruit Extract, Portulaca Oleracea Extract, Citrus Limon (Lemon) Fruit Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ALOE PROPOLIS SOOTHING
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69998-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69998-100-02 1 in 1 CARTON 07/01/2016 1 NDC:69998-100-01 100 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/01/2016 Labeler - BENTON KOREA (689514965) Registrant - BENTON KOREA (689514965) Establishment Name Address ID/FEI Business Operations BENTON KOREA 689514965 repack(69998-100) Establishment Name Address ID/FEI Business Operations Ezekiel Cosmetics Co. 689061889 manufacture(69998-100)