Label: PROCTOZONE-G- glycerin suppository
- NDC Code(s): 57237-338-16, 57237-338-21, 57237-338-51, 57237-338-52
- Packager: Rising Pharma Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 12, 2025
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Tear off one suppository from the strip
- If the suppository seems soft, place it in the refrigerator before use or run cold water over it before removing the foil wrapper
- Gently remove suppository by peeling apart the wrapper (see illustration 1)
- Rub a water-based lubricant over the tip or dip it in water. It will help you slide it in smoothly
- Lie on your side and insert 1 suppository, tapered end first, about the length of your finger into the rectum (see illustration 2)
- Hold the suppository for about 15-20 minutes to allow time for it to melt
- Children 2 to under 6 years of age ...................... 1 suppository once daily
- Children under 2 years ............................................ ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROCTOZONE-G
glycerin suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57237-338 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1.2 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM STEARATE (UNII: QU7E2XA9TG) Product Characteristics Color white (clear) Score Shape BULLET Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57237-338-21 2 in 1 CARTON 07/31/2025 1 NDC:57237-338-16 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:57237-338-52 5 in 1 CARTON 07/31/2025 2 NDC:57237-338-51 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007.54 07/31/2025 Labeler - Rising Pharma Holdings, Inc. (116880195) Establishment Name Address ID/FEI Business Operations Bliss GVS Pharma Limited 675630493 manufacture(57237-338) , analysis(57237-338) , pack(57237-338)
