Label: SODIUM SALICYLATE CONCENTRATE- sodium salicylate solution

  • NDC Code(s): 51072-038-01
  • Packager: Aurora Pharmaceutical LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/14

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  • DESCRIPTION

    ACTIVE INGREDIENT
    Sodium Salicylate 48.6% w/v
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  • CALF LABEL CLAIM

    Indications For Use, Calves

    Supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g., anti-infective) therapy if necessary.

    Contraindications, Calves

    Do not use Sodium Salicylate in neonates or calves less than 2 weeks of age.

    Dosage, Calves

    40 mg Sodium Salicylate per kg body weight (4 mL per 100 lbs.) once daily, for 1–3 days. Administer orally in drinking water or milk (replacer).

    Recommended withdrawal period for all food animals following use at "usual dosages": meat 24 hours.

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  • SWINE AND POULTRY LABEL CLAIM

    Indications

    For use in the drinking water of poultry and swine as an aid in reducing pain, fever and inflammation.

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  • DIRECTIONS FOR USE

    For Analgesic and Antipyretic Use

    Water Proportioner Use:

    Add 8 ounces (236 mL) of Sodium Salicylate 48.6% Concentrate to make 1 gallon of stock solution and administer through a medicator metered at 1:128 (1 ounce per gallon). This will achieve a target dose of 11.3 mg/lb (25 mg/kg) body weight daily.

    Livestock Tank Use:

    Add 8 ounces (236 mL) of Sodium Salicylate 48.6% Concentrate to 128 gallons of drinking water. This will achieve a target dose of 11.3 mg/lb (25 mg/kg) body weight daily.

    For Anti-Inflammatory/Anti-Prostaglandin Use - Day 1

    Water Proportioner Use:

    Add 16 ounces (473 mL) of Sodium Salicylate 48.6% Concentrate to make 1 gallon of stock solution and administer through a medicator metered at 1:128 (1 ounce per gallon). This will achieve a target dose of 22.7 mg/lb (50 mg/kg) body weight daily.

    Livestock Tank Use:

    Add 16 ounces (473 mL) of Sodium Salicylate 48.6% Concentrate to 128 gallons of drinking water. This will achieve a target dose of 22.7 mg/lb (50 mg/kg) body weight daily.

    Day 2 through 7

    Water Proportioner Use:

    Add 10 ounces (296 mL) of Sodium Salicylate 48.6% Concentrate to make 1 gallon of stock solution and administer through a medicator metered at 1:128 (1 ounce per gallon). This will achieve a target dose of 13.6 mg/lb (30 mg/kg) body weight daily.

    Livestock Tank Use:

    Add 10 ounces (296 mL) of Sodium Salicylate 48.6% Concentrate to 128 gallons of drinking water. This will achieve a target dose of 13.6 mg/lb (30 mg/kg) body weight daily.

    Prepare fresh solutions daily. Repeat as necessary.

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  • Warning

    Do not administer concentrated solution by direct oral administration — gastro-intestinal irritation or overdose may occur. Do not use in piglets less than 4 weeks of age.

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  • STORAGE AND HANDLING

    Store at 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F).

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  • FOOD SAFETY WARNING

    Do not use in food-producing animals less than 1 day prior to slaughter.

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  • SPL UNCLASSIFIED SECTION

    In California, Restricted Drug - Use Only as Directed

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  • Caution

    Keep container closed when not in use. Product may solidify at cold storage temperatures. Place container in room temperature storage, which will thaw the solution, or place in warm water. Gently invert container to ensure uniformity of product.

    Gradual darkening will not affect product stability.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • SPL UNCLASSIFIED SECTION

    Take Time

    MANUFACTURED IN THE USA

    REORDER NO: 21004

    MANUFACTURED BY:
    Aurora Pharmaceutical, LLC
    NORTHFIELD, MINNESOTA 55057
    888-215-1256
    www.aurorapharmaceutical.com

    IN 50-1108 REV 12/2013

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  • PRINCIPAL DISPLAY PANEL - 3.79 Liters Bottle Label

    NDC 51072-038-01

    ORAL-PRO™

    Sodium Salicylate
    Concentrate 48.6% w/v

    For Use in Livestock Only

    Keep Out of Reach of Children

    Net Contents:
    1 Gallon (3.79 Liters)

    AURORA PHARMACEUTICAL®

    PRINCIPAL DISPLAY PANEL - 3.79 Liters Bottle Label
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  • INGREDIENTS AND APPEARANCE
    SODIUM SALICYLATE  CONCENTRATE
    sodium salicylate solution
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:51072-038
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM SALICYLATE (SALICYLIC ACID) SODIUM SALICYLATE 48.6 g  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51072-038-01 3790 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/16/2011
    Labeler - Aurora Pharmaceutical LLC (832848639)
    Establishment
    Name Address ID/FEI Business Operations
    Aurora Pharmaceutical LLC 832848639 MANUFACTURE
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