PROSANA SKIN AND BODY- ethanol gel
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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Prosana Skin and Body

Active Ingredients

Ethanol 70%

Purpose

Antiseptic.

Uses

Hand Sanitizer to 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 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, earsand mouth. In case of contact with eyes, rinseeyes thoroughly with water.

Stop use and ask a doctor

if irritation 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 Information.

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

Inactive Ingredients.

Aqua, Aloe Barbadensis (Aloe Vera) Leaf Juice,Glycerin, Isopropyl Myristate, Propylene Glycol,
Tocopheryl Acetate (Vitamin E), Aminoethyl Propanol, Carbomer, Fragrance.

Product Label

image description

PROSANA SKIN AND BODY
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81441-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81441-001-01	473 mL in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2021
2	NDC:81441-001-02	3785 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/09/2021
3	NDC:81441-001-03	946 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/09/2021
4	NDC:81441-001-04	473 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/09/2021
5	NDC:81441-001-05	177 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/09/2021
6	NDC:81441-001-06	88 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/09/2021
7	NDC:81441-001-07	3 mL in 1 PACKET; Type 0: Not a Combination Product	04/21/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/04/2021

Labeler - Bodywell Natural Skin Care Inc (201162026)

Name	Address	ID/FEI	Business Operations
Establishment
Bodywell Natural Skin Care Inc		201162026	manufacture(81441-001)