Label: PREFERRED PLUS HEMORRHOID- witch hazel cloth
- NDC Code(s): 61715-094-51
- Packager: Kinray, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Witch Hazel 50%Close
Temporarily relieves these external symptoms associated with hemorrhoids: itching, burning, irritation.Close
For external use only.
Using this product: Do not exceed the recommended daily dosage unless directed by a doctor. Do not insert into rectum or vagina using fingers or mechanical device.
Stop use and ask doctor if: Rectal bleeding occurs, condition worsens or does not improve within 7 days.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222
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 soft cloth before applying. Gently apply to the affected area by patting and then discard. Can be used up to six times daily or after each bowel movement.
- Other Information
Store at controlled room temperature 15°-30°C (59°-86°F)Close
- Inactive ingredients:
Alcohol, Citric Acid, Diazolidinyl Urea, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Sodium Citrate, Water.Close
- Principal Display Panel - Carton Label
Preferred Plus Pharmacy®
*Compare to the active ingredient in TUCKS® Medicated Pads
Maximum Strength Pain RelieverClose
- INGREDIENTS AND APPEARANCE
PREFERRED PLUS HEMORRHOID
witch hazel cloth
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-094 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34) witch hazel 500 mg in 1 L Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Alcohol (UNII: 3K9958V90M) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Citrate (UNII: 1Q73Q2JULR) Diazolidinyl Urea (UNII: H5RIZ3MPW4) Citric Acid Monohydrate (UNII: 2968PHW8QP) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-094-51 100 in 1 JAR 1 0.001 L in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/28/2014 Labeler - Kinray, Inc. (012574513) Establishment Name Address ID/FEI Business Operations Tropical Products 157469086 MANUFACTURE(61715-094)