LUVENA FEMININE WIPES- pramoxine hydrochloride cloth

LUVENA FEMININE WIPES by

Drug Labeling and Warnings

LUVENA FEMININE WIPES by is a Otc medication manufactured, distributed, or labeled by LACLEDE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

External Analgesic Towelette.

Active Ingredient

Pramoxine hydrochloride 1% w/w

Uses

Temporarily relieves itching and burning due to minor skin irritations.

Warnings

For external use only. Store at room temperature.

Avoid contact with eyes. Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days, or clears up and occur again within a few days.

Keep out of reach of children

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

Directions

Remove cloth from foil pouch. Unfold and gently wipe to clean external vaginal area. Use each towelette only once and then throw away. Use daily whenever desired to be refreshed.

Dosage

Topical use only. Use daily whenever desired to be refreshed.

Inactive Ingredients

Aloe Vera, Benzyl Alcohol, Cucumber Extract, Fragance, Menthyl Lactate, PEG-6 Caprylic/Capric Glyceride, PEG-75 Lanolin, Propylene Glycol, Purified Water, Tea Tree Oil, Witch Hazel, Lactoferrin, Lactoperoxidase, Lysozyme.

LUVENA FEMININE WIPES label

INGREDIENTS AND APPEARANCE

LUVENA FEMININE WIPES 
pramoxine hydrochloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54897-601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
PEA (UNII: W4X7H8GYFM)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
PEG-75 LANOLIN (UNII: 09179OX7TB)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)
WITCH HAZEL (UNII: 101I4J0U34)
LYSOZYME HYDROCHLORIDE (UNII: 4YRW73H69V)
LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)
TALACTOFERRIN ALFA (UNII: 7A055A9QRR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54897-601-11	1500 mg in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/04/2012

Labeler - LACLEDE, INC. (098835994)

Registrant - LACLEDE, INC. (098835994)

Establishment
Name	Address	ID/FEI	Business Operations
LACLEDE, INC.		098835994	manufacture(54897-601)