REVITADERM ANTIMICROBIAL HAND SANITIZER

 REVITADERM ANTIMICROBIAL HAND SANITIZER

Drug Labeling and Warnings

Drug Details

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REVITADERM ANTIMICROBIAL HAND SANITIZER- antimicrobial hand sanitizer gel 
Blaine Labs, 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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 REVITADERM ANTIMICROBIAL HAND SANITIZER

Drug Facts

ACTIVE INGREDIENT

ETHANOL 63%

PURPOSE

ANTIMICROBIAL

USES:

  • TO DECREASE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE
  • RECOMMENDED FOR REPEATED USE​​

WARNINGS:

  • FOR EXTERNAL USE ONLY - HANDS
  • WHEN USING THIS PRODUCT KEEP OUT OF EYES
  • IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER
  • AVOID CONTACT WITH BROKEN SKIN
  • DO NOT INHALE OR INGEST

FLAMMABL. KEEP AWAY FROM HEAT AND FLAME.

KEEP OUT OF REACH OF CHILDREN.

  • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS:

  •  WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING
  •  FOR CHILDREN UNDER 6 USE ONLY UNDER ADULT SUPERVISION
  •  NOT RECOMMENDED FOR INFANTS

OTHER INFORMATION:

  • DO NOT STORE ABOVE 105º​F
  • MAY DISCOLOR SOME FABRICS
  • HARMFUL TO WOOD FINISHED AND PLASTICS

INACTIVE INGREDIENTS:

​DEIONIZED WATER, DENATURED ETHANOL, GLYCERIN, HYDROXYPROPYLCELLULOSE, 

FRAGRANCE (PARFUM), ALOE BARBADENSIS LEAF EXTRACT, FD&C YELLOW 5, FD&C BLUE 1

Package Labeling

NDC# 63347-001-01

REVITADERM®

ANTIMICROBIAL HAND SANITIZER

8 FL OZ (236.59 Ml)

MANUCFACTURED BY:                         QUESTIONS OR COMMENTS?                             

BLAINE LABS, INC.                              800.307.8818 | BLAINELABS.COM

11037 LOCKPORT PLACE                      M-F, 8:00 AM-5:00 PM (PSTY)

SANTA FE SPRINGS, CA  90670

                                                                    MADE IN THE U.S.A.

08100-P-LBL02          REV20200316

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REVITADERM ANTIMICROBIAL HAND SANITIZER 
antimicrobial hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63347-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL146.070 mg  in 236.59 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63347-001-01236.59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/16/2020
Labeler - Blaine Labs, Inc. (017314571)
Registrant - Blaine Labs, Inc. (017314571)
Establishment
NameAddressID/FEIBusiness Operations
Blaine Labs, Inc.017314571manufacture(63347-001)

Revised: 3/2020
 
Blaine Labs, Inc.


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