Label: PROSANA SKIN AND BODY- ethanol gel
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NDC Code(s):
81441-001-01,
81441-001-02,
81441-001-03,
81441-001-04, view more81441-001-05, 81441-001-06, 81441-001-07
- Packager: Bodywell Natural Skin Care Inc
- Category: HUMAN OTC DRUG LABEL
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 April 24, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 Label
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INGREDIENTS AND APPEARANCE
PROSANA SKIN AND BODY
ethanol gelProduct 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 04/21/2023 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(81441-001)