SANINTA HAND SANITIZING GEL- alcohol liquid

Saninta Hand Sanitizing Gel by

Drug Labeling and Warnings

Saninta Hand Sanitizing Gel by is a Otc medication manufactured, distributed, or labeled by LL Pharma, LL Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Isopropyl alcohol 70% v/v

Purpose

Antiseptic

Use

Antiseptic skin cleanser to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. For occasional and personal domestic use.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

Do not use

• In children less than 2 months of age
• On open skin wounds

When using this product

When using this product Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

• Rub hands thoroughly for at least 30 seconds. Allow to dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

• Store between 15ºC - 30ºC (59º-86ºF)
• Avoid freezing and excessive heat above 40ºC (104ºF).

Inactive ingredients

Aminomethylpropanol, Caprylyl glycol, Carbomer copolymer type B, Glycerin, Isopropyl myristate, Purified Water, Tocopherol acetate (Vitamin E)

Questions or Comments?

Questions or Comments? Tel.: 1-833-336-6159

Package Label - Principal Display Panel

NDC: 81351-002-01

Product No.: 002-01

Saninta Hand Sanitizing Gel

70% v/v Isopropyl Alcohol USP

Effective for hand sanitizing

Kills harmful bacteria

Moisturizing with Vitamin E

Manufactured by:

LL Pharma Inc.

5789 rue Cypihot, Saint-Laurent (Montreal), Quebec H4S 1R3

Made in Canada

4 oz

www.llpharmainc.com

Do not use if security seal is broken.

Pull the safety seal to open.

Flip open the cap. Close the cap when done dispensing the product.

UPC Code

LOT #: XXXX

EXP.: MM/YYYY

F004 Rev. 1 FEB 2021

INGREDIENTS AND APPEARANCE

SANINTA HAND SANITIZING GEL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81351-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81351-002-01	118.3 mL in 1 PACKET; Type 0: Not a Combination Product	03/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	03/15/2021

Labeler - LL Pharma (206925146)

Registrant - LL Pharma (206925146)

Establishment
Name	Address	ID/FEI	Business Operations
LL Pharma Inc.		206925146	manufacture(81351-002) , analysis(81351-002) , label(81351-002) , pack(81351-002)