Label: CALAMINE- calamine, pramoxine hcl lotion
- NDC Code(s): 76162-336-30
- Packager: Topco associates LLC
- 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 24, 2022
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- Active ingredients
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
DISTRIBUTED BY TOPCO ASSOCIATES LLC,
ELK GROVE VILLAGE, IL 60007
TOPCO VIJa0622 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com
Quality Guaranteed
Visit here for more information: http://topbrnds.com/4901jm
*This product is not manufactured or distributed by Bausch Health US, LLC, distributer of Caladryl Lotion Calamine Plus Itch Reliever
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INGREDIENTS AND APPEARANCE
CALAMINE
calamine, pramoxine hcl lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-336 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 80 mg in 1 mL PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) CAMPHOR (NATURAL) (UNII: N20HL7Q941) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LAVENDER OIL (UNII: ZBP1YXW0H8) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ROSEMARY OIL (UNII: 8LGU7VM393) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-336-30 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/21/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/21/2009 Labeler - Topco associates LLC (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(76162-336) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(76162-336)