Label: PROCTOSAN CREAM- ratanhia, aesculus hippocastanum, collinsonia canadensis, paeonia officinalis, negundo cream
- NDC Code(s): 62106-3159-0
- Packager: Seroyal USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated July 14, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
Warnings
For external and intrarectal use only.Do not use this product with an applicator if the introduction of the applicator into the
rectum causes additional pain. Consult a doctor promptly.When using this product do not exceed the recommended daily dosage unless directed by a doctor.
Stop use and ask a doctor
In case of bleeding.
If condition worsens or does not improve within 7 days.
If pregnant or breastfeeding, ask a health professional before use.Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
-
DOSAGE & ADMINISTRATION
Directions
Adults: When practical, cleanse the affected
area with mild soap and warm water and rinse
thoroughly. Gently dry by patting or blotting
with toilet tissue or a soft cloth before
application of this product. Apply a small
amount on affected area in the morning and at
night and after each bowel movement, or as
recommended by your healthcare practitioner.
FOR INTRARECTAL USE: Attach applicator
to tube. Lubricate applicator well, then gently
insert applicator into the rectum. Squeeze
tube to release a small amount of cream into
the rectum. Gently remove applicator and
thoroughly cleanse applicator after each use.
Children: Use under the direction of your
healthcare practitioner. -
INDICATIONS & USAGE
Uses
For the temporary relief of symptoms associated with hemorrhoids.Directions
Adults: When practical, cleanse the affected
area with mild soap and warm water and rinse
thoroughly. Gently dry by patting or blotting
with toilet tissue or a soft cloth before
application of this product. Apply a small
amount on affected area in the morning and at
night and after each bowel movement, or as
recommended by your healthcare practitioner.
FOR INTRARECTAL USE: Attach applicator
to tube. Lubricate applicator well, then gently
insert applicator into the rectum. Squeeze
tube to release a small amount of cream into
the rectum. Gently remove applicator and
thoroughly cleanse applicator after each use.
Children: Use under the direction of your
healthcare practitioner. - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PROCTOSAN CREAM
ratanhia, aesculus hippocastanum, collinsonia canadensis, paeonia officinalis, negundo creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-3159 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT 1 [hp_X] in 40 g COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT 1 [hp_X] in 40 g PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT 1 [hp_X] in 40 g HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 1 [hp_X] in 40 g ACER NEGUNDO INNER BARK (UNII: 9GB215FRJX) (ACER NEGUNDO INNER BARK - UNII:9GB215FRJX) ACER NEGUNDO INNER BARK 1 [hp_X] in 40 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-3159-0 1 in 1 CARTON 12/17/2015 1 40 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/17/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-3159)
