Prosana Skin and Body by Bodywell Natural Skin Care Inc Prosana Skin and Body

Prosana Skin and Body by

Drug Labeling and Warnings

Prosana Skin and Body by is a Otc medication manufactured, distributed, or labeled by Bodywell Natural Skin Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROSANA SKIN AND BODY- ethanol gel 
Bodywell Natural Skin Care Inc

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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 productkeep 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

PROSANA SKIN AND BODY 
ethanol gel

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	04/21/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	01/04/2021	01/01/2023

Labeler - Bodywell Natural Skin Care Inc (201162026)

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

Revised: 12/2024

Document Id: 2a301f1c-1db6-c27d-e063-6294a90a93f1

34390-5

Set id: 720002ac-b074-47c9-979d-621b86d75604

Version: 5

Effective Time: 20241226