SURE PROTECT HAND SANITIZING- alcohol gel

SURE PROTECT HAND SANITIZING by

Drug Labeling and Warnings

SURE PROTECT HAND SANITIZING by is a Otc medication manufactured, distributed, or labeled by E-House Korea Holdings International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol Denat. 62%v/v

Purpose

Antimicrobial

Use

• Helps reduce bacteria on the skin.
• Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire, sparks and sources of ignition. Do not store above 104°F/40°C

WHEN USING

When using this product

• keep out of eyes. In case of contact with eyes, flush thoroughly with water. 
• Avoid contact with broken skin.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Put directly on hands and rub in thoroughly.
• For children under 6, use adult supervision.
• Not recommended for infant.

Inactive ingredients

Water, Glycerin, Butylene Glycol, Carbomer, Triethanolamine, Camellia Sinensis Leaf Extract, Melaleuca, Alternifolia (Tea Tree) Extract, Centella Asiatica Extract, Portulaca Oleracea

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SURE PROTECT HAND SANITIZING 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50387-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
PURSLANE (UNII: M6S840WXG5)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50387-001-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	09/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/17/2020

Labeler - E-House Korea Holdings International (688527548)