HAND SANITIZING- alcohol gel

HAND SANITIZING by

Drug Labeling and Warnings

HAND SANITIZING by is a Otc medication manufactured, distributed, or labeled by Sigan Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Alcohol 62%

Purpose

Antiseptic

Uses

To decrease bacteria on hands.

Warnings

For external use only.

Flammable, keep away from fire or flame.

When using this product

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• Avoid contact with broken skin.
• Do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact Poison Control Center immediately.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

• Do not store above 105°F.
• May discolor some fabrics.
• Harmful to wood finishes and plastics.
• You may report a serious adverse reaction to this product to: Ganz U.S.A., LLC #043, 60 Industrial Parkway, Cheektowaga, New York, 14227-9903

Inactive ingredients

Water, Fragrance, Glycerin, Triethanolamine, PEG-7 Glyceryl Cocoate, Hydrolyzed Jojoba Esters, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Urtica Dioica (Nettle) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Yellow 6.

PRINCIPAL DISPLAY PANEL - 232 mL Bottle Label

time & again™

HAND SANITIZING GEL

Formulated with Glycerin,
Aloe and Jojoba to Moisturize.

Kills harmful bacteria and germs.

MANDARIN

232 mL 7.8 fl. OZ.

INGREDIENTS AND APPEARANCE

HAND SANITIZING   MANDARIN
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65365-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
GLYCERYL COCOATE (UNII: WVK1CT5994)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
JOJOBA OIL (UNII: 724GKU717M)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
SAGE (UNII: 065C5D077J)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
ROSEMARY (UNII: IJ67X351P9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65365-002-01	232 mL in 1 BOTTLE, PUMP
2	NDC: 65365-002-02	59 mL in 1 BOTTLE
3	NDC: 65365-002-03	15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	01/01/2011

Labeler - Sigan Industries (255106239)