ActiveClean OTC Spray Hand Sanitizer

ACTIVECLEAN- ethanol sda 3c 200 aerosol, spray
CleanSpot, 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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Shake container. Use enough product to throughly cover hands. Rub hands together briskly until dry. Children under 6 use only with adult supervision.

For External Use only. Flammable. Keep away from fire or flame.When using the product, do not use it in or near the eyes. In case of contact, rinse eyes throughly with water. Stop use and ask a doctor if irritation or rash appears and lasts. If swallowed get medical help or contact a PoisonControl Center right away.

water, isopropyl alcohol (rubbing alcohol), beeswax, apricit seed oil, tocopherol (Vitamin E), essential oils of lemon and peppermint,(epsilon) - polylysine

Antimicrobial

Ethanol 62% v/v

Keep out of reach of children.

Hand sanitizer to help reduce bacteria on skin that could cause disease
Recommended for repeated use

ACTIVECLEAN
ethanol sda 3c 200 aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71012-111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	1 mL in 1 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	1 mL in 1 mL
APRICOT SEED OIL (UNII: 54JB35T06A)	1 mL in 1 mL
LEMON OIL (UNII: I9GRO824LL)	1 mL in 1 mL
PEPPERMINT OIL (UNII: AV092KU4JH)	1 mL in 1 mL

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71012-111-60	1 in 1 CONTAINER	12/01/2016
1		3 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/01/2016

Labeler - CleanSpot, Inc. (078510110)

Name	Address	ID/FEI	Business Operations
Establishment
CleanSpot, Inc.		078510110	manufacture(71012-111)