ESSENTIALS HAND SANITIZER- alcohol gel 
MCRL Overseas Printing 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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Active Ingredient

Ethyl Alcohol 70%

Purpose

Sanitizer

Uses

Warnings

For external use only-hands. Use only as directed. Excessive use or prolonged exposure may cause irritation to skin. Discontinue use if rash, redness or itching appears. 

Flammable. Keep away from heat or flame.

When using this product

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children.

In case of accidental ingestion seek professional assistance or contact a poison control center immedietly.

Directions

Put a thumb size amount in your palm and  rub hands together briskly until dry.

Other information:

Inactive ingredients

Water, glycerin, propylene Glycol, carbomer, sodium hydroxide   

Package Label - Principal Display Panel

label 60 mL

Label

ESSENTIALS HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76626-003
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76626-003-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
2NDC:76626-003-0260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
3NDC:76626-003-03237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
4NDC:76626-003-04100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
5NDC:76626-003-05300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
6NDC:76626-003-06500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
7NDC:76626-003-071000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/17/2020
Labeler - MCRL Overseas Printing Inc (257078621)
Establishment
NameAddressID/FEIBusiness Operations
Huizhou Bliss Commodity Co. Ltd.417467331manufacture(76626-003)

Revised: 4/2020
Document Id: f7988004-9d06-4205-91f4-411263ca492a
Set id: 501e720c-7114-4765-833f-7a1233421792
Version: 1
Effective Time: 20200417
 
MCRL Overseas Printing Inc