HAND SANITIZER- alcohol gel 
SKYMAX VIETNAM COMPANY LIMITED

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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Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Recommended for repeated use.

For handwashing to decrease bacteria on the skin.

Warnings

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

Do not use

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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

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

Other information

Inactive ingredients

aqua, carbomer 940, trolamine, hydro peroxide, glycerin, fragrance, vitamin e

Package Label - Principal Display Panel

100 mL NDC: 81650-100- 01

81650-100-01

250 mL NDC: 81650-100- 02

81650-100-02

500 mL NDC: 81650-100- 03

81650-100-03

1000 mL NDC: 81650-100- 04

81650-100-04

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81650-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.02 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.19 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.33 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.15 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.41 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 20.78 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81650-100-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2021
2NDC:81650-100-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2021
3NDC:81650-100-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2021
4NDC:81650-100-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/2021
Labeler - SKYMAX VIETNAM COMPANY LIMITED (555655220)
Registrant - SKYMAX VIETNAM COMPANY LIMITED (555655220)
Establishment
NameAddressID/FEIBusiness Operations
SKYMAX VIETNAM COMPANY LIMITED556548577manufacture(81650-100)

Revised: 3/2021
Document Id: bd2d080a-b76d-e241-e053-2995a90aeefa
Set id: bc99ad3c-e8bd-355d-e053-2995a90af783
Version: 2
Effective Time: 20210310
 
SKYMAX VIETNAM COMPANY LIMITED