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NDC 50804-0822-43 Witch Hazel 979 mg/mL Details

Witch Hazel 979 mg/mL

Witch Hazel is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Perrigo Direct, Inc.. The primary component is WITCH HAZEL.

Product Information

NDC	50804-0822
Product ID	50804-822_00c219b4-8752-414c-9f93-00f393ba5748
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Witch Hazel
Proprietary Name Suffix	n/a
Non-Proprietary Name	Witch Hazel
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	979
Active Ingredient Units	mg/mL
Substance Name	WITCH HAZEL
Labeler Name	Perrigo Direct, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0822-43 (50804082243)

Pricing Information	N/A
NDC Package Code	50804-822-43
Billing NDC	50804082243
Package	473 mL in 1 BOTTLE, PLASTIC (50804-822-43)
Marketing Start Date	2011-04-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8efb1f5e-566f-4d8e-bdef-bf3ac70dd7e3 Details

Active ingredient

Witch hazel 86%

Purpose

Astringent

Use

for relief of minor skin irritations due to:

insect bites
minor cuts
minor scrapes

Warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as often as needed

Inactive ingredient

alcohol 14% by volume

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Dickinson Brands, Inc., distributor of T.N Dickinson Witch Hazel*

Distributed By: Geiss, Destin & Dun, Inc

Peachtree City, GA 30269

www.valuelabels.com

Principal Panel Display

GOOD SENSE

Witch Hazel USP

Hammamelis Water

Astringent

For relief of minor skin irritations due to:

Insect bites
Minor cuts
Minor scrapes

Compare to active ingredients of T.N. Dickinson's Witch Hazel*

100% SATISFACTION GUARANTEED

Square bottles ues less plastic than a similarly sized round bottle

Recyclable (if available in your area)

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

WITCH HAZEL

witch hazel liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-822
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	979 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-822-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	04/22/2011

Labeler - Perrigo Direct, Inc. (076059836)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(50804-822)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(50804-822)

Revised: 9/2022

Document Id: 00c219b4-8752-414c-9f93-00f393ba5748

Set id: 8efb1f5e-566f-4d8e-bdef-bf3ac70dd7e3

Version: 14

Effective Time: 20220912