Label: NAAMAN- allantoin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61221-010-01 - Packager: LEADER GREEN 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 August 30, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
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 and usage
- Dosage and administration
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAAMAN
allantoin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61221-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.25 mg in 50 mL Inactive Ingredients Ingredient Name Strength PONCIRUS TRIFOLIATA FRUIT (UNII: 44445L49J2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61221-010-01 50 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/01/2013 Labeler - LEADER GREEN CO., LTD. (688735493) Registrant - LEADER GREEN CO., LTD. (688735493) Establishment Name Address ID/FEI Business Operations LEADER GREEN CO., LTD. 688735493 manufacture(61221-010)