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.

----------

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

IMAGE

SUPER HANDS- HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78903-518
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78903-518-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/202001/27/2022
2NDC: 78903-518-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/202001/27/2022
3NDC: 78903-518-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/202001/27/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/13/202001/27/2022
Labeler - Christine Valmy Inc. (054522248)
Establishment
NameAddressID/FEIBusiness Operations
Christine Valmy Inc.054522248manufacture(78903-518)

Revised: 2/2022
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.