NDC | 63766-004-01, 63766-004-02 |
Set ID | 90963011-c636-452c-a3f5-6368e139fe3e |
Category | HUMAN OTC DRUG LABEL |
Packager | Avlon Industries, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART358H |
- Drug Facts
- INDICATIONS & USAGE
- Warnings
- Ask a doctor if
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
-
Inactive Ingredients
Water/Aqua/Eau, Mineral Oil, Petrolatum, Beeswax, Cetyl Alcohol, Lanolin, Sodium Borate, Polysorbate 60,
Polysorbate 80, Carthamus Tinctorius (Safflower) Seed Oil, Eugenia Caryophyllus (Clove) Flower Extract,
Glyceryl Stearate, Menthol, Sulfur, Perfume, BHT, Methylisothiazolinone, A-Isomenthyl Ionone, Benzyl Alcohol,
Benzyl Benzoate, Benzyl Cinnamate, Benzyl Salicylate, Butylphenyl Methylpropional, Cinnamal Alcohol, Citronellol,
Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Hydroxyisohexyl 3-cyclohexane Carboxaldehyde, d-Limonene, Linalool.
- SPL UNCLASSIFIED SECTION
- Package Label. Principal Display Panel
-
INGREDIENTS AND APPEARANCE
KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF
pyrithione zinc lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63766-004 Route of Administration Topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) YELLOW WAX (UNII: 2ZA36H0S2V) CETYL ALCOHOL (UNII: 936JST6JCN) LANOLIN (UNII: 7EV65EAW6H) SODIUM BORATE (UNII: 91MBZ8H3QO) POLYSORBATE 60 (UNII: CAL22UVI4M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SAFFLOWER OIL (UNII: 65UEH262IS) CLOVE (UNII: K48IKT5321) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MENTHOL (UNII: L7T10EIP3A) SULFUR (UNII: 70FD1KFU70) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZYL BENZOATE (UNII: N863NB338G) BENZYL CINNAMATE (UNII: V67O3RO97U) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) CINNAMYL ALCOHOL (UNII: SS8YOP444F) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) GERANIOL (UNII: L837108USY) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63766-004-01 60 mL in 1 TUBE; Type 0: Not a Combination Product 06/18/2009 2 NDC:63766-004-02 7.5 mL in 1 POUCH; Type 0: Not a Combination Product 06/18/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 06/18/2009 Labeler - Avlon Industries, Inc. (121278626) Establishment Name Address ID/FEI Business Operations Avlon Industries, Inc. 121278626 manufacture(63766-004)