SurelyWell HAND SANITIZER GEL

SurelyWell HAND SANITIZER Gel by

Drug Labeling and Warnings

SurelyWell HAND SANITIZER Gel by is a Otc medication manufactured, distributed, or labeled by Surelywell, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SURELYWELL HAND SANITIZER GEL- isopropyl alcohol gel 
Surelywell, 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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SurelyWell HAND SANITIZER GEL

Drug Facts

Active ingredient

Isopropyl Alcohol v/v 70%

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria on skin. For use when soap and water are unavailable

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product

Avoid contact with eyes, ears, and mouth.

If contact occurs, rinse thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if irritation and redness develops.

Keep out of reach of children.

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

Directions

Wet hands thoroughly with product and rub into skin until dry. Children Under 6 years of age should be supervised by an adult when using.

Other information

Do not store above 104°F/40°C

Inactive ingredients

Water (Aqua), Ammonium Polyacryloyldimethyl Taurate, Aloe Barbadensis Leaf Juice.

70% Alcohol

Distributed by and
Manufactured for:
SurelyWell, Inc
16192 Coastal Hwy
Lewes DE 19958

Packaging

SURELYWELL HAND SANITIZER GEL 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90094-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90094-065-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2021	08/10/2021
2	NDC: 90094-065-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2021	08/10/2021
3	NDC: 90094-065-98	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2021	08/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/04/2021	08/10/2021

Labeler - Surelywell, Inc. (117469094)

Revised: 8/2021

Document Id: ca6367fc-d8eb-1573-e053-2a95a90a4cf7

34390-5

Set id: eb715a12-22a3-48e2-aab0-2350a849ca18

Version: 2

Effective Time: 20210825