OMV ANTI-ITCH BIKINI- oatmeal cream

OMV Anti-Itch Bikini by

Drug Labeling and Warnings

OMV Anti-Itch Bikini by is a Otc medication manufactured, distributed, or labeled by Combe Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

OMV! by Vagisil™ Bikini Anti-Itch Serum

DRUG FACTS

Active Ingredient

Colloidal Oatmeal 0.01%

Purpose

Skin Protectant

Use

Provides temporary skin protection and relief of minor skin irritation and external itching due to rashes.

Warnings

For External Use Only

When using this product

do not get into 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 in a few days.

Keep out of reach of children.

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

Directions

Apply to irritated and chafed skin as often as needed for instant relief.

Inactive Ingredients

Water, Cetyl Ethylhexanoate, Glycerin, PEG-40 Hydrogenated Castor Oil, Glyceryl Dilaurate, Phenoxyethanol, Caprylyl Glycol, Sodium Polyacrylate, Dimethicone, Ceteareth-20, Glyceryl Oleate, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cyclopentasiloxane, Trideceth-6, Disodium EDTA, Sodium Hydroxide, PEG/PPG-18/18 Dimethicone, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL

OMV! by Vagisil™ Bikini Anti-Itch Serum

~soothes bikini & intimate area

with colloidal oatmeal

~pH balanced

vanilla clementine

Gynecologist Tested

Net. Wt. 1.7oz (48 g)

INGREDIENTS AND APPEARANCE

OMV ANTI-ITCH BIKINI 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11509-5282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
WATER (UNII: 059QF0KO0R)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERYL OLEATE (UNII: 4PC054V79P)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11509-5282-1	1 in 1 CARTON	01/01/2020
1		48 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/01/2020

Labeler - Combe Incorporated (002406502)