LUVENA FEMININE WIPES- pramoxine hydrochloride cloth
LACLEDE, 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.

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LUVENA FEMININE WIPES

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

LUVENA FEMININE WIPES
pramoxine hydrochloride cloth

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54897-601-11	1500 mg in 1 POUCH; Type 0: Not a Combination Product	04/04/2012	09/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	04/04/2012	09/30/2020

Labeler - LACLEDE, INC. (098835994)

Registrant - LACLEDE, INC. (098835994)

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

Revised: 2/2023

Document Id: 7cfef3a9-1d9e-4280-8e23-f0184e958d9f

Set id: b607f6a7-f2e2-4af8-8ae5-9d66f1b1fb06

Version: 4

Effective Time: 20230213

LACLEDE, INC.