GRIME STOPPERS INSTANT HAND SANITIZER- alcohol gel 
EMCO Electric International

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.

----------

Hand Sanitizer

ACTIVE INGREDIENT(S)

Ethyl Alcohol 70% v/v

PURPOSE

Anitmicrobial

DOSAGE & ADMINISTRATION

Topical Gel applied to outer surface of the body, specifically hands.

USE

Gel hand sanitizer to help reduce bacteria on the skin that could cause disease or illness. Repeat use as needed.

WARNINGS

When using this product

  • Keep out of eyes, ears, and mouth. In case of contact, flush thoroughly with water.
  • Avoid contact with broken wounds.
  • Do not ingest or inhale.

Stop use and ask a doctor

if irritation or rash appears and persists more than 72 hours.

Keep out of the reach of children.

  • If swallowed, get medical help or contact the Poison Control Center right away.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

Grime STOPPERS Instant Hand Sanitizer Gel

53mL NDC: 63436-006-02

53mL Label

500ml NDC: 63436-006-16

500mL Label

3.78mL NDC: 63436-006-28

3.78L Label

GRIME STOPPERS INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63436-006
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
GLYCERIN (UNII: PDC6A3C0OX) 0.2 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 29.18 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.26 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.26 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63436-006-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/09/2020
2NDC:63436-006-0253 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2020
3NDC:63436-006-283.79 mL in 1 JUG; Type 0: Not a Combination Product09/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/09/2020
Labeler - EMCO Electric International (122921948)

Revised: 2/2021
Document Id: bb9f4d52-5e93-5c3c-e053-2a95a90a6c1b
Set id: aee4c0e7-6de8-325f-e053-2995a90a94a8
Version: 2
Effective Time: 20210218
 
EMCO Electric International