TOPCARE MEDICATED WIPES

Dosage form: cloth
Ingredients: WITCH HAZEL 0.5mL in 1mL
Labeler: TOPCO ASSOCIATES LLC
NDC Code: 36800-330

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 Facts

Active ingredient                                                              Purpose

Witch Hazel, 50% v/v...........................................................Astringent

Uses

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

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.

If pregnant or breast-feeding, 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.

Directions

Adults and children 12 years and older- Up to 6 times daily or after each bowel movement

Children under 12- Consult a doctor

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 discard.  Apply to the affected area up to 6 times daily or after each bowel movement.

Store at room temperature: 15o-30oC (59o-86oF)

Inactive ingredients

aloe barbadensis gel, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

7711 GROSS POINT ROAD

SKOKIE, IL 60077

QUESTIONS? 1-888-423-0139

Made in China

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TOPCARE MEDICATED WIPES 
witch hazel cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-330
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
DIAZOLIDINYL UREA 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM CITRATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:36800-330-4848 APPLICATOR (APPLICATOR) in 1 PACKAGE
14.5 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/01/2012
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 03/2012
 
TOPCO ASSOCIATES LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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