LUVENA FEMININE WIPES

Dosage form: cloth
Ingredients: PRAMOXINE HYDROCHLORIDE 10mg in 1000mg
Labeler: LACLEDE, INC.
NDC Code: 54897-601

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.

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

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 label

LUVENA FEMININE WIPES 
pramoxine hydrochloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54897-601
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE10 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA WHOLE 
BENZYL ALCOHOL 
CUCUMBER FRUIT OIL 
PEA 
MENTHYL LACTATE, (-)- 
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES 
PEG-75 LANOLIN 
PROPYLENE GLYCOL 
WATER 
TEA TREE OIL 
WITCH HAZEL 
LYSOZYME HYDROCHLORIDE 
LACTOPEROXIDASE BOVINE 
TALACTOFERRIN ALFA 
Packaging
#Item CodePackage Description
1NDC:54897-601-111500 mg in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/04/2012
Labeler - LACLEDE, INC. (098835994)
Registrant - LACLEDE, INC. (098835994)
Establishment
NameAddressID/FEIOperations
LACLEDE, INC.098835994manufacture(54897-601)

Revised: 07/2012
 
LACLEDE, INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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