EQUATE HAND SANITIZER- 70% alcohol sanitizer gel
BELVEDERE INTERNATIONAL 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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uses

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

Directions

PLACE ENOUGH PRODUCT IN YOUR PALM TO THOROUGHLY COVER YOUR HANDS AND RUB HANDS TOGETHER UNTIL DRY

CHILDREN UNDER 6 YEARS SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

Inactive ingredients

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, FRAGRANCE, GLYCERIN, ISOPROPYL ALCOHOL, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TETRAHYDROXYPROPYL ETHYLENEDIAMINE, TOCOPHERYL ACETATE, WATER

Active Ingredient

ETHYL ALCOHOL 70%

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children, in case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Warnings

FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT, FIRE OR FLAME.

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOUROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS.

purpose

ANTISEPTIC

label

label.jpg

image description

EQUATE HAND SANITIZER
70% alcohol sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60742-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
EDETOL (UNII: Q4R969U9FR)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60742-006-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/22/2017

Labeler - BELVEDERE INTERNATIONAL INC. (247836356)

Registrant - BELVEDERE INTERNATIONAL INC. (247836356)

Name	Address	ID/FEI	Business Operations
Establishment
BELVEDERE INTERNATIONAL INC.		247836356	manufacture(60742-006)