SKYGEL HAND SANITIZER by ISD MEDITECH SDN. BHD.

SKYGEL HAND SANITIZER by

Drug Labeling and Warnings

SKYGEL HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by ISD MEDITECH SDN. BHD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKYGEL HAND SANITIZER- isopropyl alcohol liquid 
ISD MEDITECH SDN. BHD.

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.

----------

Active Ingredient

Isopropyl Alcohol 75% v/v.   

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Not to be taken orally.

Flammable. Keep away from heat or flame.

Do not use

  • in 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. Do not inhale or ingest.
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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry. Do not wipe off.
  • 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) and direct sunlight.

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Product Label

image description

SKYGEL HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79098-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79098-002-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/202012/24/2021
2NDC: 79098-002-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/202012/24/2021
3NDC: 79098-002-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/202012/24/2021
4NDC: 79098-002-04500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/202012/24/2021
5NDC: 79098-002-051000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/202012/24/2021
6NDC: 79098-002-065000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/202012/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/202012/24/2021
Labeler - ISD MEDITECH SDN. BHD. (659306967)

Revised: 10/2021
 

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