Label: PROSANA SKIN AND BODY- ethanol spray
- NDC Code(s): 81441-002-01, 81441-002-02, 81441-002-03, 81441-002-04
- Packager: Bodywell Natural Skin Care Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated January 17, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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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.
- Directions.
- Other Information.
- Inactive Ingredients
- Product Image
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INGREDIENTS AND APPEARANCE
PROSANA SKIN AND BODY
ethanol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81441-002 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) TOCOPHEROL (UNII: R0ZB2556P8) LAVENDER OIL (UNII: ZBP1YXW0H8) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81441-002-01 118 mL in 1 PACKAGE; Type 0: Not a Combination Product 01/04/2021 2 NDC:81441-002-02 3785 mL in 1 PACKAGE; Type 0: Not a Combination Product 02/09/2021 3 NDC:81441-002-03 236 mL in 1 PACKAGE; Type 0: Not a Combination Product 02/09/2021 4 NDC:81441-002-04 118 mL in 1 PACKAGE; Type 0: Not a Combination Product 02/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/04/2021 Labeler - Bodywell Natural Skin Care Inc (201162026) Establishment Name Address ID/FEI Business Operations Bodywell Natural Skin Care Inc 201162026 manufacture(81441-002)