Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame

When using this product

do not use in the eyes
discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

store at 15 0 to 25 0 C (59 0 to 77 0 F)
may discolor certain fabrics or surfaces
you may report a serious adverse reaction to this product to 800-275-3433

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate, fragrance, PEG-60 almond glycerides, propylene glycol, tocopheryl acetate, purified water, triisopropanolamine

Questions

info@safeguardmedical.com www.safeguardmedical.com

Directions

place enough product in your palm to thoroughly cover your hands. Rub hands together until dry.
for children under 6 years of age, use only under adult supervision. Not recommended for infants.

Principal Display Panel

Enter section text here Hand Sanitizer labeling

INSTANT HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59898-420
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59898-420-15	24 in 1 CARTON	04/15/2010	06/30/2022
1	NDC:59898-420-14	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:59898-420-13	24 in 1 CARTON	04/15/2011	06/30/2022
2	NDC:59898-420-12	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:59898-420-11	24 in 1 CARTON	04/15/2011	06/30/2022
3	NDC:59898-420-10	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:59898-420-02	144 in 1 BOX, UNIT-DOSE	04/15/2011
4		1.3 mL in 1 PACKET; Type 0: Not a Combination Product
5	NDC:59898-420-01	1728 in 1 CARTON	04/15/2011
5		1.3 mL in 1 PACKET; Type 0: Not a Combination Product
6	NDC:59898-420-03	25 in 1 BOX, UNIT-DOSE	04/15/2011
6		1.3 mL in 1 PACKET; Type 0: Not a Combination Product
7	NDC:59898-420-33	3000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2011	06/30/2022
8	NDC:59898-420-28	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2011	06/30/2022
9	NDC:59898-420-17	24 in 1 CARTON	04/15/2011	06/30/2022
9	NDC:59898-420-16	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
10	NDC:59898-420-36	0.9 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/15/2010
11	NDC:59898-420-04	10 in 1 CARTON	04/15/2010
11		0.9 mL in 1 PACKET; 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	part333E	04/15/2010

Labeler - Water-Jel Technologies (155522589)

Registrant - Water-Jel Technologies (155522589)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(59898-420)

Instant Hand Sanitizer