ROVECTIN ANTI IRRITANT BARRIER REPAIR ULTRA- dimethicone cream
SECOND FORMULA 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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ACTIVE INGREDIENT

ACTIVE INGREDIENT: DIMETHICONE 1.80%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
WATER, CYCLOPENTASILOXANE, BUTYROSPERMUM PARKII (SHEA BUTTER), HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, NIACINAMIDE, GLYCERIN, SQUALANE, CETEARYL METHICONE, PHENOXYETHANOL, RICINUS COMMUNIS (CASTOR) SEED OIL, PERSEA GRATISSIMA (AVOCADO) OIL, OLIVE GLYCERIDES, HEXYLDECANOL, POLYSORBATE 60, LINOLEIC ACID, GLYCINE SOJA (SOYBEAN) STEROLS, PHOSPHOLIPIDS, ALOE BARBADENSIS LEAF JUICE, HYDROXYETHYLCELLULOSE, ETHYLHEXYLGLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM PHYTATE, TOCOPHEROL, CERAMIDE 3, SODIUM HYDROXIDE, HAEMATOCOCCUS PLUVIALIS EXTRACT

PURPOSE

PURPOSE: SKIN PROTECTANT

WARNINGS

WARNINGS:
FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES.
STOP USE AND ASK A DOCTOR IF CONDITION WORNSENS.
DO NOT USE ON DEEP OR PUNCTURE WOUNDS.
KEEP OUT OF THE REACH OF CHILDREN.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

Directions:
Apply to face, neck, hands, feet and body.
Use as often as necessary.

DOSAGE AND ADMINISTRATION

Directions:
Apply to face, neck, hands, feet and body.
Use as often as necessary.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

ROVECTIN ANTI IRRITANT BARRIER REPAIR ULTRA
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52970-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	1.8 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Shea Butter (UNII: K49155WL9Y)
Niacinamide (UNII: 25X51I8RD4)
Glycerin (UNII: PDC6A3C0OX)
Squalane (UNII: GW89575KF9)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52970-010-01	100 mL in 1 CARTON

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/01/2012

Labeler - SECOND FORMULA INC. (557819411)

Registrant - SECOND FORMULA INC. (557819411)

Name	Address	ID/FEI	Business Operations
Establishment
SECOND FORMULA INC.		557819411	manufacture(52970-010)