Artnaturals Hand Sanitizer Natural Elements Cleansing Formula: Package Insert and Label Information

ARTNATURALS HAND SANITIZER NATURAL ELEMENTS CLEANSING FORMULA- alcohol gel
Virgin Scent 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.

Drug Facts

Active ingredient[s]

Ethyl Alcohol 62.5%

Purpose

Antiseptic

Use[s]

Hand sanitizer cap help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not use

  • On open skin wounds
  • In children less than 2 months of age

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

  • 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 inforamtion

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

Inactive ingredients

Water (Aqua), Glycerin, Fragrance / Parfum, Carbomer, Aminomethyl Propanol, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylene Glycol, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Actinidia Chinensis (Kiwi) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Punica Granatum (Pomegranate) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract.

Package Labeling:78706-003-01

Front Label
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Back Label
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Package Labeling:78706-003-02

Label2
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Package Labeling:78706-003-03

Front Label3
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Back Label3
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Package Labeling:78706-003-04

Front Label4
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Back Label4
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ARTNATURALS HAND SANITIZER NATURAL ELEMENTS CLEANSING FORMULA
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78706-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.625 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
AMINOMETHYLPROPANOL
PROPANEDIOL
JOJOBA OIL
ALOE VERA LEAF
PROPYLENE GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
HELIANTHUS ANNUUS FLOWERING TOP
KIWI FRUIT
STRAWBERRY
POMEGRANATE
BLUEBERRY
CRANBERRY
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78706-003-01 946 mL in 1 BOTTLE None
2 NDC:78706-003-02 1890 mL in 1 BOTTLE None
3 NDC:78706-003-03 3780 mL in 1 BOTTLE None
4 NDC:78706-003-04 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 03/03/2020
Labeler — Virgin Scent Inc. (034474058)
Establishment
Name Address ID/FEI Operations
GORDON LABORATORIES,INC 008328619 manufacture (78706-003)

Revised: 10/2020 Virgin Scent Inc.

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