Label: AER PRE-MOISTENED WITCH HAZEL PAD- witch hazel solution
- NDC Code(s): 50289-3250-1
- Packager: Birchwood Laboratories 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 January 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Keep Out Of Reach of Children
- Directions
- Inactive Ingredients
- AER Lid
-
INGREDIENTS AND APPEARANCE
AER PRE-MOISTENED WITCH HAZEL PAD
witch hazel solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50289-3250 Route of Administration TOPICAL, RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 500 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size 108mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50289-3250-1 40 in 1 JAR 06/28/2018 1 2.8 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M015 06/28/2018 Labeler - Birchwood Laboratories LLC (096488432)