Label: LK CLEAN GEL (ETHANOL)- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74488-001-01, 74488-004-01, 74488-005-01 - Packager: Venice Cosmetic
- 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 April 30, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Uses
- Purpose
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Warnings
For external use only. Flammable. Keep away from heat or flame.
Do not use
if you are allergic to any of the ingredients
in children less than 2 months of age
on open skin woundsWhen using this product avoid contact with 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.
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Inactive ingredients
- Keep out of reach of children
- LK Clean gel (Ethanol)
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INGREDIENTS AND APPEARANCE
LK CLEAN GEL (ETHANOL)
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74488-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE (UNII: V5VD430YW9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74488-005-01 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/09/2020 LK CLEAN GEL (ETHANOL)
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74488-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE (UNII: V5VD430YW9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74488-004-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/09/2020 LK CLEAN GEL (ETHANOL)
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74488-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE (UNII: V5VD430YW9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74488-001-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/09/2020 Labeler - Venice Cosmetic (695047082) Establishment Name Address ID/FEI Business Operations Venice Cosmetic 695047082 manufacture(74488-004, 74488-001, 74488-005)
