Label: SIGNATURE CARE MEDICATED WIPES HEMORRHOIDAL WIPES WITH WITCH HAZEL- hemorrhoidal wipes with witch hazel cloth
- NDC Code(s): 21130-800-48
- Packager: Better Living Brands LLC
- 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 August 28, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
-
DIRECTIONS
adult: 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
children under 12 years of age: consult a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENTS
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Other Uses
for 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 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.
- FOR COMMENTS OR QUESTIONS PLEASE
- Keep out of reach of children
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PRINCIPAL DISPLAY PANEL - LID LABEL
Signature Care
Quality Guaranteed
Compare to the active ingredient in Preparation H(R) Medicated Wipes*
MEDICATED WIPES
HEMORRHOIDAL WIPES WITH WITCH HAZEL
Mild, everyday wipes to ease & lessen irritation
Soothing; Gentle; Soft
Convenient; Easy to use
For hemorrhoidal & vaginal care
WITH ALOE TO SOOTHE
48 MEDICATED WIPES
5 in X 6 in (12.7 cm x 15.2 cm)
2OA9131SLI
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INGREDIENTS AND APPEARANCE
SIGNATURE CARE MEDICATED WIPES HEMORRHOIDAL WIPES WITH WITCH HAZEL
hemorrhoidal wipes with witch hazel clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-800 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) BRONOPOL (UNII: 6PU1E16C9W) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) PEG-75 LANOLIN (UNII: 09179OX7TB) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-800-48 48 in 1 CONTAINER 08/28/2020 1 252 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 08/28/2020 Labeler - Better Living Brands LLC (009137209) Registrant - Nice-Pak Products , Inc. (003778198) Establishment Name Address ID/FEI Business Operations Nice-Pak Products, Inc. 067900167 manufacture(21130-800)