Label: VITAL-SALITAR - salicylic acid, menthol and coal tar shampoo
- NDC Code(s): 60255-337-16, 60255-337-28
- Packager: Vital Animal Health
- 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.
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- ACTIVE INGREDIENT
Active Ingredients (in each dosage unit) Purpose
Salicylic Acid 3% (w/w) ................................ keratolytic
Coal Tar Solution 2% (w/w) .......................... antiseborrheic
Menthol 1% (w/w) ........................................ antipruriticClose
An antiseborrheic, mentholated, keratolytic, soap-free formulation with a unique combination of surfactants and coat conditioners. For relief of irritation, itching and skin flaking associated with seborrhea and nonspecific dermatoses.Close
- WARNINGS AND PRECAUTIONS
DO NOT USE ON CATS • For Animal Use Only • Keep out of reach of children • Wash hands after use • For topical use in dogs and horses • Avoid contact with eyes or mucous membranes • Not for otic use • If undue skin irritation develops or increases, discontinue use and consult a veterinarian.
- DOSAGE & ADMINISTRATION
Shake well before use. Wet coat thoroughly. Apply and lather Vital-SaliTar Shampoo over the entire body, allowing for 5 to 10 minutes of contact time. Rinse completely. Repeat procedure if necessary. Use once or twice weekly, or as directed by your veterinarian.
- STORAGE AND HANDLING
• Store at room temperature (59˚F - 86˚F)
• Available only through licensed veterinarians.
- SPL UNCLASSIFIED SECTION
NOT FOR SALE IN CALIFORNIA
Vital Animal Health
Manufactured in USA for:
Vital Animal Health
2031 Rand Ave.
Colorado Springs, CO 80905
- PRINCIPAL DISPLAY PANEL
for dogs and horses
Salicylic Acid 3%, Coal Tar Solution 2%, Menthol 1%
An antiseborrheic, keratolytic and antipruritic conditioning shampoo for dogs
16 FL OZ (474 ML) or 1 GALLON (3.78 L)
MADE IN THE USA
- INGREDIENTS AND APPEARANCE
salicylic acid, coal tar, menthol shampoo
Product Information Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:60255-337 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 30 mg in 1 mL MENTHOL (MENTHOL) MENTHOL 10 mg in 1 mL COAL TAR (COAL TAR) COAL TAR 20 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60255-337-16 474 mL in 1 BOTTLE, PLASTIC 2 NDC:60255-337-28 3785 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/31/2013 Labeler - Vital Animal Health (003927150) Registrant - Custom Veterinary Services, Inc. (619511483) Establishment Name Address ID/FEI Business Operations Custom Veterinary Services, Inc 619511483 manufacture