AER PRE-MOISTENED WITCH HAZEL PAD- witch hazel solution
Birchwood Laboratories LLC

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.

----------

AER 40's Drug Facts

Active Ingredient

Witch Hazel 50%

Purpose

Astringent

Uses

Temporary relief of anal itching and burning

Temporarily protects irritated tissues

Warnings

For external rectal use only

Stop use and ask doctor if

rectal bleeding or continued irritation occurs

Keep Out Of Reach of Children

Keep out of reach of children

Directions

Gently apply to affected areas by patting and then discard

Inactive Ingredients

Benzalkonium Chloride, Citric Acid, Glycerin, Methylparaben, Purified Water, Sodium Citrate

AER Lid

AER PRE-MOISTENED WITCH HAZEL PAD
witch hazel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50289-3250
Route of Administration	TOPICAL, RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	500 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M015	06/28/2018

Labeler - Birchwood Laboratories LLC (096488432)