Label: TOPCARE CALACLEAR- pramoxine hydrochloride and zinc acetate lotion lotion
- NDC Code(s): 36800-267-96
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
For external use only. Use only as directed.
Avoid contact with eyes and mucous membranes.
Ask a doctor before using
on children under 2 years of age.
When using this product. Discontinue use if
condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor.
Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
-
DOSAGE & ADMINISTRATION
Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.
Children under 2 years of age: Consult a doctor before use. - INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TOPCARE CALACLEAR
pramoxine hydrochloride and zinc acetate lotion lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-267 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CAMPHOR (NATURAL) (UNII: N20HL7Q941) ALCOHOL (UNII: 3K9958V90M) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-267-96 177 mL in 1 CONTAINER; Type 0: Not a Combination Product 07/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 07/16/2019 Labeler - TOPCO ASSOCIATES LLC (006935977) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(36800-267) , label(36800-267) , analysis(36800-267) , pack(36800-267)
