INSTANT HAND SANITIZER- alcohol gel 
Provision Medical

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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Drug Facts

Active ingredient

Ethyl

Alcohol 66.5%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on skin without soap and water.

Warnings

For external use only

Flammable, keep away from fire or flame.

Keep out of reach of children.

Do not use in eyes, if this happens, rinse thoroughly with water.

Stop use, ask a doctor if irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

Principal Display Panel - 0.9g Packet Label

Provision Medical PRODUCTS

INSTANT

HAND

SANITIZER

0.9 g (1/32 oz.)

Manufactured for

Provision Medical Products

Palm Desert, CA 92211

Principal Display Panel - 0.9g Packet Label
INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3554
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol665 mL  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe (UNII: V5VD430YW9)  
carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
d&c green no. 5 (UNII: 8J6RDU8L9X)  
d&c yellow no. 10 (UNII: 35SW5USQ3G)  
water (UNII: 059QF0KO0R)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-3554-10.9 g in 1 PACKET; Type 0: Not a Combination Product03/16/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/16/2015
Labeler - Provision Medical (036936831)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(69103-3554)

Revised: 3/2015
Document Id: 6243c52b-a546-4a99-aa00-012794d8bb8f
Set id: eefd29d1-39d2-4059-a474-c23dce0f7772
Version: 3
Effective Time: 20150316
 
Provision Medical