ALCOHOL WIPES LEMON SCENT- ethyl alcohol cloth 
Valley of the Sun Cosmetics 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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Alcohol Wipes Lemon Scent

Active Ingredients

Ethyl Alcohol 80%

Purpose

Antimicrobial

Uses

Alcohol Wipes are used to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Keep away from heat or flame.

Do not use

When using this product

Keep out of eyes, ears, and mouth. In case of contact with eyes, 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

Water (aqua), hydrogen peroxide, glycerin, aloe barbadensis (aloe vera) leaf juice, lemon fragrance (parfum)

Package Label

Alcohol Wipes Lemon Scent, 80 wipes, 454ml, NDC: 76523-002-80

Label Product picture Front

ALCOHOL WIPES LEMON SCENT 
ethyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76523-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.3 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 17.93 mL  in 100 mL
Product Characteristics
Colorwhite (White canister with blue cap) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76523-002-80454 mL in 1 CANISTER; Type 0: Not a Combination Product11/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/14/2020
Labeler - Valley of the Sun Cosmetics LLC (176470664)
Registrant - Valley of the Sun Cosmetics LLC (176470664)
Establishment
NameAddressID/FEIBusiness Operations
Valley of the Sun Cosmetics LLC176470664manufacture(76523-002)

Revised: 11/2020
Document Id: b41713fd-64b1-e9ca-e053-2995a90a31fd
Set id: b41713fd-64b0-e9ca-e053-2995a90a31fd
Version: 1
Effective Time: 20201114
 
Valley of the Sun Cosmetics LLC