Label: DERMABLEND - lactic acid concentrate

  • NDC Code(s): 48106-1316-1, 48106-1316-2, 48106-1316-3, 48106-1316-4, view more
    48106-1316-5, 48106-1316-6
  • Packager: BouMatic, LLC
  • Category: OTC ANIMAL 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 January 1, 2015

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

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    TEAT DIP CONCENTRATE

    Helps reduce the spread of organisms which may cause Mastitis

    USE DIRECTIONS

    NOT FOR HUMAN USE

    FOR EXTERNAL USE ONLY

    USE ONLY AS DIRECTED

    Do not use in concentrated form.
    Must dilute prior to use.

    To obtain a 0.5% Lactic Acid, 0.21%
    DDBSA solution and 2.% emollients,
    add 1 part DermaBlend to 9 parts water
    and mix thoroughly.

    Active Ingredient (Lactic Acid 5%,
    DDBSA 2.0%)
    Emollients (Glycerin 20%)

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  • PRECAUTIONS

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    CAUTION

    KEEP OUT OF REACH OF CHILDREN

    NOT FOR HUMAN USE

    FIRST AID:
    If in eyes: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses,
    if present after the first 5 minutes, then continue rinsing. Contact a physician immediately.

    If swallowed: Have person sip a glass of water if able to swallow. Do not give anything to an unconscious person. Do not
    induce vomiting. Contact a physician immediately.

    If breathing difficulty occurs: Move person to fresh air. Contact a physician immediately.

    If on skin: Take off contaminated clothing. Rinse skin with soap and water. If irritation develops and persists, contact a physician.

    Have the product container or label with you when going for treatment, calling a physician, the emergency
    number listed on this label or MSDS, or a poison control center.

    PRECAUTION: Avoid eye contact. Do not ingest. Do not mix with any chemicals except as directed.

    STORAGE: Store in a closed container away from sources of heat. If product becomes frozen, thaw and mix
    well before use.

    SEE MATERIAL SAFETY DATA SHEET

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    DERMABLEND 
    lactic acid concentrate
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:48106-1316
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID 50 g  in 1 L
    DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9) (DODECYLBENZENESULFONIC ACID - UNII:60NSK897G9) DODECYLBENZENESULFONIC ACID 20 g  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48106-1316-5 208 L in 1 DRUM
    2 NDC:48106-1316-6 1040 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
    3 NDC:48106-1316-1 3.8 L in 1 DRUM
    4 NDC:48106-1316-2 18.9 L in 1 DRUM
    5 NDC:48106-1316-3 56.8 L in 1 DRUM
    6 NDC:48106-1316-4 114 L in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/2015
    Labeler - BouMatic, LLC (124727400)
    Registrant - BouMatic, LLC (124727400)
    Establishment
    Name Address ID/FEI Business Operations
    BouMatic, LLC 124727400 api manufacture, manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Knapp Manufacturing 063012827 api manufacture, manufacture
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