SAFETY FIRST HAND SANITIZER 70% ETOH- ethyl alcohol gel 
LifeTech Pharma, LLC

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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Hand Sanitizer

This hand Sanitizer was manufactured according to the Federal Register 21 CFR 310, utilizing:

a. USP/FCC grade Ethyl alcohol 99%

b. Distilled/purified water

c. Hydroxypropylcellulose (as Vegetable Cellulose)

d. Glycerin USP/FCC grade

e. Limonene (as fragrance)

f. Aloe Vera extract

Active Ingredient(s)

Ethyl alcohol 70%

Purpose

Antiseptic, Hand Sanitizer

Uses

Decreases bacteria on skin.

Warnings

For external use only. Flammable, keep away from flames.

When using this product

When using this product keep out of eyes. In case of contact, flush eyes with water.

Stop use

Stop use and ask doctor if irritation and redness develop.

Keep out of reach

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

Directions

• Rub hands thoroughly with product and allow to dry.
• For children under 6, use only under adult supervision.

Other Information

• Store below 110ºF (43ºC).
• May discolor certain fabrics or surfaces.

Inactive ingredients

Inactive ingredients Distilled Water,
Vegetable Cellulose,
Glycerin, Aloe Vera, Fragrance.

8 oz Packaging & Label - Principal Display Panel

8 oz label8 FL Oz (236 mL) - NDC: 75270-532-08

8 FL OZ (236 mL) NDC: 75270-532-08

16 oz Packaging & Label - Principal Display Panel

16 FL Oz ( 473 mL) - NDC: 75270-532-16 16 oz Pump Bottle

16 oz label

32 oz Packaging & Label - Principal Display Panel

32 FL Oz ( 946 mL) - NDC: 75270-532-32

32 oz bottle

32 oz label

128 oz Packaging & Label - Principal Display Panel

1 Gallon (3.78 L) 128 FL Oz - NDC: 75270-105-28

128 oz Pump Bottle128 oz Label

SAFETY FIRST HAND SANITIZER 70% ETOH 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75270-532
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70.7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517) 0.01 mL  in 100 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.1 mL  in 100 mL
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) 0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.7 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75270-532-08236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2020
2NDC:75270-532-16473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2020
3NDC:75270-532-32946 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2020
4NDC:75270-532-283780 mL in 1 JUG; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2020
Labeler - LifeTech Pharma, LLC (057492812)
Registrant - LifeTech Pharma, LLC (057492812)
Establishment
NameAddressID/FEIBusiness Operations
LifeTech Pharma057492812manufacture(75270-532)

Revised: 1/2021
Document Id: c128a74c-78a8-7faa-e053-2a95a90a53ce
Set id: c128a74c-78a7-7faa-e053-2a95a90a53ce
Version: 1
Effective Time: 20210101
 
LifeTech Pharma, LLC