VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA- hydrocortisone acetate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Combe Incorporated

INN (International Name):

HYDROCORTISONE ACETATE

Composition:

HYDROCORTISONE ACETATE 280 mg in 28 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-itch For temporary external feminine itching.

Authorization status:

OTC monograph not final

Summary of Product characteristics

VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA-
HYDROCORTISONE ACETATE CREAM
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 ANTI-ITCH CRÈME MAXIMUM STRENGTH, SENSITIVE SKIN FORMULA
VAGISIL SENSITIVE SKIN ANTI-ITCH CREME
DRUG FACTS
ACTIVE INGREDIENTS
Hydrocortisone Acetate 1%
PURPOS E
Anti-itch
US E
For temporary external feminine 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.
DO NOT USE IF
YOU HAVE A VAGINAL DISCHARGE. CONSULT A PHYSICIAN.
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 and older
Apply to external vaginal area not more than 3
to 4 times a day
children under 12 years
consult a doctor
INACTIVE INGREDIENTS:
water, cetyl ethylhexanoate, glycerin, PEG-40 hydrogenated castor oil,
glyceryl dilaurate, dimethicone,
colloidal oatmeal, aloe barbadensis leaf extract, sodium polyacrylate,
caprylyl glycol, ceteareth-20,
glyceryl oleate, acrylates/C10-30 alkyl acrylate crosspolymer,
cyclopentasiloxane, trideceth-6, sodium
hydroxide, disodium EDTA, sorbic acid, PEG/PPG-18/18 dimethicone,
tocopheryl acetate,
maltodextrin, phenoxyethanol.
PRINCIPAL DISPLAY PANEL
VAGISIL SENSITIVE SKIN ANTI-ITCH CREME, 1% HYDROCORTISONE
Net. Wt. 1 oz. (28 g)
VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN
FORMULA
hydrocortisone acetate cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:1150 9 -510 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -
UNII:WI4X0 X7BPJ)
HYDROCORTISONE
ACETATE
28 0 mg
in 28 g
INAC