PURADOR- alcohol gel 
Vitals Cosmetics International

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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Active Ingredient

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Use

Warnings

For external use only.

Flammable. Keep away from heat or flame

When using this product Avoid contact with eyes, ears and mouth. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Decolorized Aloe Barbadensis Leaf Juice*, Ammonium Polyacryloyldimethyl Taurate, Tocopheryl Acetate (Vitamin E), Pyrus Malus (Apple)
Fruit Extract*, Glycerin*, Lavandula Angustifolia (Lavender) Oil**, Melaleuca Alternifolia (Tea Tree) Leaf Oil*, Mentha Piperita (Peppermint) Oil*, Eucalyptus Globulus (Eucalyptus) Oil*.

Package Label - Principal Display Panel

Label

PURADOR 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69019-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
APPLE (UNII: B423VGH5S9)  
GLYCERIN (UNII: PDC6A3C0OX)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
TEA LEAF OIL (UNII: VC855RRT77)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69019-002-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/26/2020
Labeler - Vitals Cosmetics International (049656991)

Revised: 3/2022
Document Id: db83cebf-da78-219e-e053-2a95a90a46c0
Set id: 87784a00-c38a-430f-828d-9600c0be2a54
Version: 3
Effective Time: 20220331
 
Vitals Cosmetics International