GERM ATTACK HAND SANITIZER- alcohol gel
Natural Essentials, 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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Drug Facts

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

Flammable: Keep away from fire or flame.

When using this product

Do not use in eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor if

irritation and redness develop and persist.

Keep out of reach of children.

If swallowed, get medical help promptly.

Directions

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

Other information

Store under 105°F

Inactive Ingredients

Acrylates/Vinyl Isodecanoate Crosspolymer, Aloe Barbadensis Leaf, PEG-6, PEG-12 Dimethicone, Water. May contain fragrance.

Principal Display Panel – 473 ml Bottle Label

GERM
ATTACK

70% ALCOHOL
HAND SANITIZER
GEL
WITH MOISTURIZING ALOE VERA

16 fl oz (473 ml)

MADE IN USA

Principal Display Panel – 473 ml Bottle Label

Principal Display Panel – 119 ml Tube Label

GERM
ATTACK

70% ALCOHOL
HAND SANITIZER
GEL
WITH MOISTURIZING
ALOE VERA

4 fl oz (119 ml)

Principal Display Panel – 119 ml Tube Label

GERM ATTACK HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66902-743
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	0.70 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66902-743-12	3785 mL in 1 JUG; Type 0: Not a Combination Product	06/26/2020
2	NDC:66902-743-64	1892 mL in 1 JUG; Type 0: Not a Combination Product	06/26/2020
3	NDC:66902-743-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/26/2020
4	NDC:66902-743-04	119 mL in 1 TUBE; Type 0: Not a Combination Product	07/02/2020
5	NDC:66902-743-02	60 mL in 1 TUBE; Type 0: Not a Combination Product	07/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/26/2020

Labeler - Natural Essentials, Inc. (947484713)

Name	Address	ID/FEI	Business Operations
Establishment
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-743)

Revised: 7/2020

Document Id: 53f7b7e1-c86d-48c9-b15f-7b547c3be1e9

Set id: 4a7b88ca-5053-4a25-9db5-762cf564e683

Version: 1

Effective Time: 20200702

Natural Essentials, Inc.