REVITADERM ANTIMICROBIAL HAND SANITIZER- antimicrobial hand sanitizer gel

REVITADERM ANTIMICROBIAL HAND SANITIZER by

Drug Labeling and Warnings

REVITADERM ANTIMICROBIAL HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Blaine Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENT

ETHANOL 63%

PURPOSE

PURPOSE

ANTIMICROBIAL

INDICATIONS & USAGE

USES:

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

WARNINGS

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

SPL UNCLASSIFIED SECTION

FLAMMABL. KEEP AWAY FROM HEAT AND FLAME.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

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

DOSAGE & ADMINISTRATION

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

SPL UNCLASSIFIED SECTION

OTHER INFORMATION:​​

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

INACTIVE INGREDIENT

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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INGREDIENTS AND APPEARANCE

REVITADERM ANTIMICROBIAL HAND SANITIZER 
antimicrobial hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-001-01	236.59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/16/2020

Labeler - Blaine Labs, Inc. (017314571)

Registrant - Blaine Labs, Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs, Inc.		017314571	manufacture(63347-001)