Label: MEDICATED WIPES- witch hazel solution
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Contains inactivated NDC Code(s)
NDC Code(s): 49348-559-08 - Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated February 12, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
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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
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Other uses
- for vaginal care - cleanse the area by gently wiping, patting or blotting with pad and discard. Repeat as needed.
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for use as a moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.
- INACTIVE INGREDIENTS
- QUESTIONS
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PACKAGE INFORMATION - PEEL AWAY LABEL
Sunmark TM
COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*
pre-moistened
NDC 49348-559-08
medicated wipes
for hemorrhoidal and vaginal care
Witch Hazel, 50%
FOUR TIMES LARGER THAN MEDICATED PADS
48 FLUSHABLE MEDICATED WIPES
5.6 X 6.0 IN (14.3 X 15.2 cm)
Distributed by McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
*This product is not manufactured or distributed by Whitehail-Robins Healthcare, owner of the registered trademark PREPARATION H®.
Peel and Reseal
LIFT HERE
Tear off and discard strip to begin use
Rev. A
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PACKAGE INFORMATION - SLEEVE
Sunmark TM
COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*
NDC 49348-559-08
pre-moistened
medicated wipes
For hemorrhoidal and vaginal care
Contains Aloe
Witch Hazel, 50%
FOUR TIMES LARGER THAN MEDICATED PADS
48 FLUSHABLE MEDICATED WIPES
5.6 X 6.0 IN (14.3 X 15.2 cm)
*This product is not manufactured or distributed by Whitehail-Robins Healthcare, owner of the registered trademark PREPARATION H®.
Another Quality Product
Distributed by McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
Please visit us
at www.sunmarkbrand.com
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INGREDIENTS AND APPEARANCE
MEDICATED WIPES
witch hazel solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-559 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34) witch hazel 0.50 mL in 1 mL Inactive Ingredients Ingredient Name Strength aloe vera leaf (UNII: ZY81Z83H0X) citric acid monohydrate (UNII: 2968PHW8QP) diazolidinylurea (UNII: H5RIZ3MPW4) glycerin (UNII: PDC6A3C0OX) methylparaben (UNII: A2I8C7HI9T) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) sodium citrate (UNII: 1Q73Q2JULR) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-559-08 48 in 1 PACKAGE 1 4.5 mL in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 06/19/2003 Labeler - McKesson (177667227)