HYGIENIC CLEANSING PAD

Main information

  • Trade name:
  • HYGIENIC CLEANSING PAD - witch hazel solution
  • Composition:
  • witch hazel 0.50 mL in 1 mL
  • Administration route:
  • RECTAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HYGIENIC CLEANSING PAD - witch hazel solution
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Hemorrhoidal Astringent

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 49035-751-21
  • Last update:
  • 29-05-2019

Summary of Product characteristics: dosage, interactions, side effects

HYGIENIC CLEANSING PAD - witch hazel solution

Wal-Mart Stores Inc

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.

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DRUG FACTS

ACTIVE INGREDIENT

Witch Hazel 50% v/v

PURPOSE

Hemorrhoidal Astringent

USE

For temporary relief of local discomfort, burning, and irritation associated with hemorrhoids

WARNINGS

For external use only. Avoid contact with eyes.

Consult a doctor

if condition worsens or does not improve within 7 days

in case of bleeding

before exceeding the recommended dosage

Do not

put this product into rectum using fingers or any mechanical device or applicator

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

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 each application of this

product. Gently apply to the affected area by patting and then discard. Apply to the affected area up

to 6 times daily or after each bowel movement.

Children under 12 years of age: consult a doctor.

OTHER INFORMATION

Store at room temperature: 15°- 30° C (59° - 86° F)

OTHER USES

For vaginal care - cleanse the area by gently wiping, patting or blotting with pad and discard. Repeat as

needed.

INACTIVE INGREDIENTS

water, glycerin, alcohol 7% v/v, sodium citrate, propylene glycol, citric acid, diazolidinyl urea,

methylparaben, propylparaben

LABEL INFORMATION

NDC 49035-751-21

EQUATE

Compare to Tucks® active ingredient*

Hygienic Cleansing Pads

pre-moistened hemorrhoidal/vaginal pads with witch hazel

MEDICATED PADS

100 PADS

Hygienic cleansing action for temporary relief of external rectal and vaginal itching and burning

For your protection, jar is sealed. Remove lid. If seal is broken or missing, do not use.

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the

registered trademark TUCKS®.

Manufactured by: Triad Pharmaceuticals, Inc. 700 West North Shore Drive, Hartland, WI 53029

Serious side effects associated with use of this product can be reported to the phone number provided

below.

1-800-288-1288

HYGIENIC CLEANSING PAD

witch hazel solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 0 35-751

Route of Administration

RECTAL, TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

witch ha zel (UNII: 10 1I4J0 U34) (witch hazel - UNII:10 1I4J0 U34)

witch hazel

0 .50 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

citric a cid mo no hydra te (UNII: 29 6 8 PHW8 QP)

dia zo lidinylurea (UNII: H5RIZ3MPW4)

g lycerin (UNII: PDC6 A3C0 OX)

methylpa ra ben (UNII: A2I8 C7HI9 T)

pro pylene g lyco l (UNII: 6 DC9 Q16 7V3)

pro pylpa ra ben (UNII: Z8 IX2SC1OH)

so dium citra te (UNII: 1Q73Q2JULR)

wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 0 35-751-21

10 0 in 1 JAR

1

2.5 mL in 1 APPLICATOR

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt346

0 3/0 1/20 0 7

Labeler -

Wal-Mart Stores Inc (051957769)

Registrant -

H and P Industries, Inc. dba T riad Group (050259597)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

H and P Industries, Inc. dba Triad Gro up

0 50 259 59 7

ma nufa c ture

Wal-Mart Stores Inc

Revised: 12/2009