Label: OHL O2- allantoin spray
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Contains inactivated NDC Code(s)
NDC Code(s): 60899-040-01 - Packager: AMAROS CO., LTD.
- 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.
Drug Label Information
Updated April 11, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Butylene Glycol, Sodium PCA, Alcohol Denat., Sodium Hyaluronate, Sodium Citrate, Portulaca Oleracea Extract, Glycine Soja (Soybean) Seed Extract, Anthemis Nobilis Flower/Leaf Extract, Morus Alba Bark Extract, PEG-60 Hydrogenated Castor Oil, Hydrolyzed Collagen, Tocopheryl Acetate, Caprylyl Glycol, Caprylhydroxamic Acid, Citrus Paradisi (Grapefruit) Fruit Extract, Centella Asiatica Extract, Lavandula Angustifolia (Lavender) Oil, Hamamelis Virginiana (Witch Hazel) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Disodium EDTA, Spirulina Maxima Extract, Piper Methysticum Leaf/Root/Stem Extract, Lavandula Angustifolia (Lavender) Extract, Human Oligopeptide-1, Copper Tripeptide-1, Ceramide 3.
- PURPOSE
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WARNINGS
Warnings: 1. In case of having following symptoms after using this product, 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 AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OHL O2
allantoin sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60899-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.3 mg in 60 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60899-040-01 60 mL in 1 CARTON; Type 0: Not a Combination Product 09/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/01/2013 Labeler - AMAROS CO., LTD. (690338801) Registrant - AMAROS CO., LTD. (690338801) Establishment Name Address ID/FEI Business Operations AMAROS CO., LTD. 690338801 manufacture(60899-040)