QUALITY CHOICE MEDICATED WIPES- witch hazel cloth 
American Hygienics Corporation

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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QUALITY CHOICE Medicated Wipes

Drug Facts

Active ingredient

Witch hazel 50%

Purpose

Anorectal/Astringent

Uses

• temporarily relieves the local itching and discomfort associated with hemorrhoids
• aids in protecting irritated anorectal areas  • temporarily relieves irritation and burning

Warnings

For external use only

When using this product
• do not use more than directed unless told to do so by a doctor
• do not put directly in the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if
• rectal bleeding occurs
• condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• open the lid on the top of the wipes pouch  • peel back wipes seal, remove completely and discard
• grab the top wipe at the edge of the center fold and pull out of pouch 
• close lid after each use to retain moisture 
• adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area
• use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard. Do Not Flush.
• children under 12 years of age: consult a doctor

Other information

• store at room temperature 20-25°C (68-77°F)  • protect from excessive heat

Inactive ingredients

alcohol, aloe vera leaf, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Compare to the Active Ingredient in PREPARATION H®

Hemorrhoidal/Vaginal Wipes with Witch Hazel

Soothes & Comforts Irritated Areas

Pre-moistened Cooling Wipes

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Other Uses:
For external vaginal care – cleanse the area by gently wiping, patting or blotting. Repeat as needed.
For use as a moist compress – if necessary, first cleanse the area. Fold new wipe to desired size and place in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.

TAMPER EVIDENT: DO NOT USE IF POUCH IS OPEN OR DAMAGED.

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Preparation H® Medicated Wipes.

**Decolorized. Prop 65.

Made in China

Packaging

Medicated Wipes

QUALITY CHOICE MEDICATED WIPES 
witch hazel cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15533-396
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15533-396-0148 in 1 POUCH07/28/2021
14.68 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/28/2021
Labeler - American Hygienics Corporation (545198454)
Establishment
NameAddressID/FEIBusiness Operations
American Hygienics Corporation545198454manufacture(15533-396)

Revised: 8/2021
Document Id: faa7c23b-0edf-4a1c-a374-708856a6cb08
Set id: bde399cf-fd37-43e1-9692-b512e14f97b9
Version: 1
Effective Time: 20210805
 
American Hygienics Corporation