Label: NO-SCAR OINT.- centella titrated extract neomycin sulfate, hydrocortisone acetate, neomycin sulfate ointment

  • NDC Code(s): 58354-113-01, 58354-113-02
  • Packager: Cho-A Pharm.Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated February 22, 2019

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  • Active Ingredients

    Centella Titrated Extract 10mg

    Hydrocortisone Acetate 10mg

    Neomycin Sulfate 3.5 mg

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  • Purpose

    Scar control

    external analgesic

    First Aid Antibiotic

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  • Keep out of reach of children

    If swallowed, get medical help or contact Poison Control Center right away.

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  • Uses

    Minor cuts

    Scrapes

    Burns

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  • Warnings

    For external use only.

    Ask a doctor before use in case of: Deep puncture wounds, Animal bites, Or serious burns

    Do not use: if you are allergic to any of the ingredients, in the eyes, over large areas of the body, longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if: the condition worsens, or if symptoms persist for more than 7days or clear up and occur again within a few days.

    Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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  • Directions

    Adults and children 2 years of age and older: apply to the affected area 1 to 2 times daily

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  • Inactive Ingredients

    Polyethylene glycol, White Petrolatum, Light Liquid Paraffin

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  • No-SCAR Oint.
  • INGREDIENTS AND APPEARANCE
    NO-SCAR OINT. 
    centella titrated extract neomycin sulfate, hydrocortisone acetate, neomycin sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58354-113
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA 10 mg  in 10 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 10 g
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 10 mg  in 10 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 70 mg  in 10 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58354-113-02 1 in 1 CARTON 02/22/2019
    1 NDC:58354-113-01 10 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/22/2019
    Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
    Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
    Establishment
    Name Address ID/FEI Business Operations
    Cho-A Pharm.Co.,Ltd. 688056831 manufacture(58354-113)
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