Label: CLEAR ANTI ITCH- pramoxine hcl, zinc acetate lotion
- NDC Code(s): 36800-218-30
- Packager: TOPCO ASSOCIATES
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 29, 2022
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- Active Ingredients
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- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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- Inactive ingredients
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SPL UNCLASSIFIED SECTION
DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL60007
TOPCP VIJA0622 Questions? 1-888-423-0139
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This product is not manufactured of distributed by Bausch Health US, LLC,
Distributer of Caladryl Clear Lotion
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INGREDIENTS AND APPEARANCE
CLEAR ANTI ITCH
pramoxine hcl, zinc acetate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-218 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 CATION 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BENZOIC ACID (UNII: 8SKN0B0MIM) CAMPHOR (NATURAL) (UNII: N20HL7Q941) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) glycerin (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYSORBATE 40 (UNII: STI11B5A2X) ROSEMARY OIL (UNII: 8LGU7VM393) sodium citrate (UNII: 1Q73Q2JULR) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-218-30 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/03/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/03/2009 Labeler - TOPCO ASSOCIATES (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(36800-218) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(36800-218)