AER PRE-MOISTENED WITCH HAZEL PAD- witch hazel solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Birchwood Laboratories LLC

INN (Kansainvälinen yleisnimi):

Witch Hazel

Koostumus:

Witch Hazel 0.5 mL in 1 mL

Antoreitti:

TOPICAL

Prescription tyyppi:

OTC DRUG

Käyttöaiheet:

Astringent Temporary relief of anal itching and burning Temporarily protects irritated tissues

Valtuutuksen tilan:

OTC monograph final

Valmisteyhteenveto

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
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)
WITCH HAZEL
500 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
Birchwood Laboratories LLC
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
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
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 INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
M015
06/28/2018
LABELER -
Birchwood Laboratories LLC (096488432)
Revised: 1/2023