Super Hands™ HAND SANITIZER

Super Hands- Hand Sanitizer by

Drug Labeling and Warnings

Super Hands- Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Christine Valmy Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPER HANDS- HAND SANITIZER- ethyl alcohol gel 
Christine Valmy 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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Super Hands™ HAND SANITIZER

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use For use when soap and water are not available.

Warnings

For external use only.
Flammable. Keep away from fire or flame.
Do Not Use
On children less than 2 months of age
On open skin wounds
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 if irritation or rash occurs.

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Deionized Water, Propanediol, Glycerin, Tocopheryl Acetate, Carbomer, PEG-7 Glyceryl Cocoate, Aloe Barbadensis(Aloe Vera) Extract, Polysorbate 20, Citrus Nobilis (Mandarin Orange) Peel Oil, Triethanolamine, Blue 1 (CI 42090)

With Aloe & Vitamin E

70% Alcohol

MADE IN USA

Made in our factory in Pine Brook, NJ

www.getsuperhands.com

Packaging

SUPER HANDS- HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78903-518
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MANDARIN OIL (UNII: NJO720F72R)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78903-518-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020	01/27/2022
2	NDC: 78903-518-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020	01/27/2022
3	NDC: 78903-518-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020	01/27/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/13/2020	01/27/2022

Labeler - Christine Valmy Inc. (054522248)

Establishment
Name	Address	ID/FEI	Business Operations
Christine Valmy Inc.		054522248	manufacture(78903-518)

Revised: 2/2022

Document Id: fa3d2002-227b-41f0-936c-039f303a23b7

34390-5

Set id: d1a6c04c-9dca-4197-b939-c48e3e841130

Version: 3

Effective Time: 20220203