WET WIPES- phenoxyethanol swab 
Hangzhou Caring Cleaning Commodity Co.,Ltd

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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WET WIPES

Active Ingredient(s)

Quaternary ammonium, Phenoxyethanol

Purpose

Antiseptic

Use

Decreases bacteria on skin. Recommended for repeated use

Warnings

For external use only. Flammable, keep product away from fire or flame.

Do not use over large areas of the body if you are allergic to any of the ingredients when using this product,avoid contact with eyes and face.If contact occurs,flush thoroughly with water.Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Do not use

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

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.

Inactive ingredients

Water,Glycerin,Polysorbate 20,Aloe Barbadensis Leaf Extract,Chamomilla Recutita (Matricaria) Flower Extract,Tocopheryl Acetate,Citric Acid

Directions

For adults and children of 2 years and over.children under 2 years ask a doctor before use.

Wet hands thoroughly with product and allow to dry without wiping.

Package Label - Principal Display Panel

100 PCS IN 1 PAIL NDC: 78936-002-01

Label

WET WIPES 
phenoxyethanol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78936-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CHAMOMILE (UNII: FGL3685T2X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78936-002-01100 g in 1 PAIL; Type 0: Not a Combination Product06/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34706/18/2020
Labeler - Hangzhou Caring Cleaning Commodity Co.,Ltd (413905445)
Registrant - Hangzhou Caring Cleaning Commodity Co.,Ltd (413905445)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Caring Cleaning Commodity Co.,Ltd413905445manufacture(78936-002)

Revised: 6/2020
Document Id: a84c95b7-155a-12da-e053-2995a90a3916
Set id: a84c95b7-1559-12da-e053-2995a90a3916
Version: 1
Effective Time: 20200617
 
Hangzhou Caring Cleaning Commodity Co.,Ltd