ANTISEPTIC- alcohol gel 
Welly Health PCB

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

Uses

Warnings

For external use only.

Flammable, keep away from fire or flame.

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

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

Keep this and all drugs out of the reach of children. 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 – Box Label

OINTMENT REFILLS

Welly FIRST AID

Clean Hands
INSTANT HAND SANITIZER

COUNT 12

NET WT 0.03 oz (0.9g)

TOTAL NET WT 0.36 oz (10.8g)

Ethyl Alcohol

Principal Display Panel – Box Label
ANTISEPTIC 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol665 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
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:72663-111-1212 in 1 BOX08/27/2019
1NDC:72663-111-230.9 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/27/2019
Labeler - Welly Health PCB (116766884)

Revised: 11/2019
Document Id: ccaa8a68-c8f9-40ea-b075-187216a4fdd5
Set id: 515a2c1d-2c2c-4389-b042-0e880661db64
Version: 2
Effective Time: 20191105
 
Welly Health PCB