VELNUE- ethanol liquid 
Bodywell Natural Skin Care Inc

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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Velnue Foaming Hand Sanitizer Citrus Smile

Active Ingredients

Ethanol 70%

Purpose

Antiseptic.

Uses

Warnings

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

Do not use

• in children less than 2 months of age.
• on open skin or wounds.

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions.

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information.

• Store between 15-30C (59-86F)
• Avoid freezing & excessive heat above 40C(104F)

Inactive Ingredients.

Water, Bis-PEG-12 Dimethicone, Glycerin, PEG-7 Glyceryl Cocoate, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Reticulata (Tangerine) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E)

Product Image

image description

VELNUE 
ethanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81441-004
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
WATER (UNII: 059QF0KO0R)  
BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
GRAPEFRUIT OIL (UNII: YR377U58W9)  
MANDARIN OIL (UNII: NJO720F72R)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81441-004-01350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/20/2021
2NDC:81441-004-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/20/2021
Labeler - Bodywell Natural Skin Care Inc (201162026)
Establishment
NameAddressID/FEIBusiness Operations
Bodywell Natural Skin Care Inc201162026manufacture(81441-004)

Revised: 1/2021
Document Id: b98c8c28-01fd-26ed-e053-2a95a90ad2c7
Set id: fb151bff-e716-4761-867b-f79180d7e79a
Version: 1
Effective Time: 20210123
 
Bodywell Natural Skin Care Inc