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:

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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
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_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._
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WITCH HAZEL
822
ACTIVE INGREDIENT
Witch hazel 86%
PURPOS E
Astringent
US E
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
Select Brand
U.S.P. WITCH HAZEL
Gently Tones Skin
• Astringent for face + body
• Cleans + refreshes
Square bottle uses less plastic than a similarly sized round bottle.
recyclable (If available in your area)
16 FL OZ (473 mL)
WITCH HAZEL
witch hazel liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:15127-8 22
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
WITCH HA ZEL (UNII: 10 1I4J0 U34) (WITCH HAZEL - UNII:10 1I4J0 U34)
Witch Hazel
8 6 kg in 10 0 L
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
SELECT BRAND DIST.
DATE
DATE
1
NDC:15127-8 22-
34
.236 L in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n
Pro duc t
0 3/10 /20 11
2
NDC:15127-8 22-
43
.473 L in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n
Pro duc t
0 3/10 /20 11
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt346
0 3/10 /20 11
LABELER -
SELECT BRAND DIST . (012578514)
REGISTRANT -
Vi-Jon, Inc. (790752542)
ESTABLISHMENT
NAME
AD D RE S S
ID/FE