WITCH HAZEL liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)

Available from:

DZA Brands

INN (International Name):

WITCH HAZEL

Composition:

WITCH HAZEL 86 kg in 100 L

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

for relief of minor skin irritations due to: • insect bites • minor cuts • minor scrapes

Authorization status:

OTC monograph final

Summary of Product characteristics

WITCH HAZEL- WITCH HAZEL LIQUID
DZA BRANDS
_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._
----------
WITCH HAZEL
822.001/822AA
ACTIVE INGREDIENT
Witch hazel 80%
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
This product is not manufactured or distributed by Dickinson Brands
Inc., distributor of
T. N. Dickinson's Witch Hazel*
Distributed by: DZA Brands
LLC 2110 Executive Drive
Salisbury, NC 28147
For product question or concerns contact us at: 1-866-322-2439
PRINCIPAL DISPLAY PANEL
healthy accents astringent
witch hazel
cleans and refreshes • soothes + relieves minor skin irritations
compare to T.N. Dickinson Witch Hazel*
16 FL OZ (1PT) 473mL
WITCH HAZEL
witch hazel liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55316-822
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DZA Brands
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)
WITCH HAZEL
86 kg in 100 L
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALCOHOL (UNII: 3K9958V90M)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:55316-
822-43
.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
01/31/2008
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part347
01/31/2008
LABELER -
DZA Brands (090322194)
REGISTRANT -
Vi-Jon, LLC (790752