INTEGRITY MADE LLC ALOE SCENT WITH VITAMIN E HANDSANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

Integrity Made LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Do not use - For children less than 2 months of age - on open skin wounds Uses: Handsanitizer to help reduce bacteria that potentially can cause disease. For use when soap and wateer are not available Stop use and ask a doctor if - irritation or rash occurs - condition persists for more than 72 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

INTEGRITY MADE LLC ALOE SCENT WITH VITAMIN E HANDSANITIZER- ALCOHOL
GEL
INTEGRITY MADE LLC
_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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INTEGRITY MADE LLC ALOE SCENT WITH VITAMIN E
DRUG ACTIVE
Active Ingredients
Purpose
Ethyl Alcohol 70%v/v
Antiseptic
Uses:
Hand sanitizer to help reduce bacteria that potentially can cause
disease.
For use when soap and water are not available.
Stop Use amd ask a doctor if
irritation or rash occurs
condition persists for more than 72 hours
Do not use
For children less than 2 months of age
on open skin wounds
Keep out of reach of children
If swallowed, get medical help, or contact a Posion ControlCenter
Right Away
Uses:
Handsanitizer to help reduce bacteria that potentially can cause
disease. For use when soap and wateer
are not available
Warnings
For external use only : hands
Flammable keep away from heat or flame
Do not ingest or inhale
Stop use and ask a doctor if
irritation or rash occurs
condition persists for more than 72 hours
Store between 15 - 30C (59 - 86 F)
Avoidfreezing and storage above 40C (140F)
Fragrance
Glycerin
Isopropyl Myristate
PEG- and AMP- Acrylates/ Vinyl Isodecanoate crosspolymer
Tocopheryl Acetate
Water
INTEGRITY MADE LLC ALOE SCENT WITH VITAMIN E HANDSANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:9 0 118 -0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)
ALCOHOL
0 .7 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)
Integrity Made LLC
.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END D