Country: United States
Language: English
Source: NLM (National Library of Medicine)
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)
Perrigo Direct, Inc.
WITCH HAZEL
WITCH HAZEL 979 mg in 1 mL
TOPICAL
OTC DRUG
Astringent for relief of minor skin irritations due to: - insect bites - minor cuts - minor scrapes - condition worsens or symptoms persist for more than 7 days
OTC monograph final
WITCH HAZEL- WITCH HAZEL LIQUID PERRIGO DIRECT, INC. _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 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 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 WITCH HAZEL witch hazel liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:50804-822 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 979 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ALCOHOL (UNII: 3K9958V90M) Perrigo Direct, Inc. PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:50804- 822-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/22/2011 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH Read the complete document