HAND SANITIZER- alcohol gel 
NTML Group Ltd

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.

----------

INMO 70% Alcohol Hand Gel (30ml)

Hand Sanitizer with NDC 00000-000 is a a human over the counter drug product labeled by NTML Group Ltd. The generic name of Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For handwashing to decrease bacteria on the skin

Recommended for repeated use

Warnings

For external use only

Flammable, keep away from fire and flame

Do not drink

If taken internally will produce serious gastric disturbances

Do not use

When using this product avoid the eyes and mucous membrane

In the case of eyes or mucous membranes contact, rinse area thoroughly with water

Stop use and ask a doctor if condition worsens, redness or irritation develops

If condition persists for more than 3 days

Keep out of reach of children. If swallowed contact a doctor or Poison Control Center immediately.

Directions

Rub dime sized amount between hands until dry

Supervise children in the use of this product

In the case of eye contact, rinse eyes thoroughly with water

Other information

Store below 105 F

May discolour some fabrics

Inactive ingredients

Aminomethyl Propanol, Carbomer, Glycerin, Propylene Glycol, Water.

Package Label - Principal Display Panel

70% Alcohol Gel

30 mL (1 fl oz) 30 ml label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77366-001
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77366-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - NTML Group Ltd (664159445)

Revised: 4/2020
Document Id: a46aa4c7-d01e-3057-e053-2a95a90a7e4a
Set id: a46aa499-ae70-2df8-e053-2a95a90a86ad
Version: 1
Effective Time: 20200429
 
NTML Group Ltd