VAGISIL MEDICATED WIPES pramoxine hydrochloride cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Pramoxine hydrochloride 1% w/w

Available from:

Combe Incorporated

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

VAGISIL MEDICATED WIPES- PRAMOXINE HYDROCHLORIDE CLOTH
COMBE INCORPORATED
_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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VAGISIL MEDICATED WIPES
VAGISIL ANTI-ITCH MEDICATED WIPES
_ACTIVE INGREDIENTS_
Pramoxine hydrochloride 1% w/w
_PURPOSE_
External analgesic towelette
_USE_
temporarily relieves itching
_WARNINGS_
FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES
STOP USE AND ASK A DOCTOR IF
condition worsens, or if symptoms persist for more than 7 days or
clear 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_
adults and children 12 years of age and older: unfold towelette and
gently pat or wipe external
vaginal area from front to back. Use each towelette only once and then
throw away. Apply to
affected area not more than 3 to 4 times daily.
children under 12 years: consult a doctor
_INACTIVE INGREDIENT_
water, polysorbate 20, glycerin, phenoxyethanol, disodium
cocoamphodiacetate, TEA-
cocoyl glutamate, methylparaben, Fragrance, Ethylparaben, disodium
EDTA, PEG-7 glyceryl cocoate,
aloe barbadensis leaf juice, tocopheryl (Vitamin E) acetate, zea mays
(corn) oil, retinyl (Vitamin
A) palmitate, cholecalciferol (Vitamin D),
_PRINCIPAL DISPLAY PANEL_
INSTANT RELIEF
FROM INTENSE ITCH
VAGISIL®
1% PRAMOXINE HYDROCHLORIDE
ANTI-ITCH MEDICATED
MAXIMUM STRENGTH WIPES
12 INDIVIDUALLY WRAPPED, FLUSHABLE WIPES
5 IN. X 7.28 IN. (12.7 CM X 18.5 CM)
PATENTED ODOR BLOCK PROTECTION
CLEANSES WHILE RELIEVING ITCH
VAGISIL MEDICATED WIPES
pramoxine hydrochloride cloth
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:1150 9 -0 375
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PRAMO XINE HYDRO CHLO RIDE (UNII: 8 8 AYB8 6 7L5) (PRAMOXINE -
UNII:0 6 8 X8 4E0 56 )
PRAMOXINE
HYDROCHLO