OTC Medication Information: NAAMAN

NAAMAN- allantoin cream
LEADER GREEN CO., LTD.

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.

ACTIVE INGREDIENT

Active ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients: PONCIRUS TRIFOLIATA FRUIT, RED CLAY POWDER, NARINGINASE, LOBELIA SPICATA LEAF, MINERAL OIL, LIMONENE, (+)-, VITAMINE C, VINCAMINE

PURPOSE

Purpose: Skin Protectant

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

Keep out of reach of children:
Keep out of reach of babies and children

Indications and usage

Indications and usage:
After basic skin care, apply adequate amount following the skin texture and gently tap to enhance absorption.

Dosage and administration

Dosage and administration:
Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NAAMAN
allantoin cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61221-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allantoin (ALLANTOIN) Allantoin 0.25 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
PONCIRUS TRIFOLIATA FRUIT
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61221-010-01 50 mL in 1 CARTON None
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 Operations
LEADER GREEN CO., LTD. 688735493 manufacture (61221-010)

Revised: 08/2013 LEADER GREEN CO., LTD.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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