Label: ANTIBACTERIAL DREAMY FLORALS- glycerin soap
ANTIBACTERIAL FRUITY ZEST- glycerin soap
ANTIBACTERIAL COOLING BREEZE- glycerin soap
ANTIBACTERIAL DELIGHTFUL SWEETNESS- glycerin soap
ANTIBACTERIAL BOLD CITRUS- glycerin soap
-
NDC Code(s):
83033-0010-1,
83033-0020-1,
83033-0030-1,
83033-0040-1, view more83033-0050-1, 83033-0060-1, 83033-0070-1, 83033-0080-1, 83033-0090-1, 83033-0100-1
- Packager: Quimicas Handal de Centroamerica SA de CV
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
-
WARNINGS
Avoid contact with eyes. Hold eye open
and rinse slowly and gently with water. Minors
should be supervised while using this product. KEEP
OUT OF REACH OF CHILDREN.
IN CASE OF INGESTION: Rinse mouth with water, seek
amedical assistance.
IN CASE OF INTOXICATION: CONSULT YOUR
DOCTOR AND PROVIDE THIS LABEL. - INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- 83033-0010
- 83033-0020
- 83033-0030
- 83033-0040
- 83033-0050
- 83033-0060
- 83033-0070
- 83033-0080
- 83033-0090
- 83033-0100
-
INGREDIENTS AND APPEARANCE
ANTIBACTERIAL DREAMY FLORALS
glycerin soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83033-0010 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 g in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g in 1 g METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g in 1 g SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) 1 g in 1 g EDETATE SODIUM (UNII: MP1J8420LU) 1 g in 1 g SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g in 1 g COCO DIETHANOLAMIDE (UNII: 92005F972D) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83033-0010-1 300 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/11/2022 ANTIBACTERIAL FRUITY ZEST
glycerin soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83033-0090 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g in 1 g Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g in 1 g WATER (UNII: 059QF0KO0R) 1 g in 1 g METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g in 1 g SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) 1 g in 1 g EDETATE SODIUM (UNII: MP1J8420LU) 1 g in 1 g SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g in 1 g COCO DIETHANOLAMIDE (UNII: 92005F972D) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83033-0090-1 500 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/11/2022 ANTIBACTERIAL COOLING BREEZE
glycerin soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83033-0050 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 g in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g in 1 g METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g in 1 g SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) 1 g in 1 g EDETATE SODIUM (UNII: MP1J8420LU) 1 g in 1 g SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g in 1 g COCO DIETHANOLAMIDE (UNII: 92005F972D) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83033-0050-1 300 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/11/2022 ANTIBACTERIAL DREAMY FLORALS
glycerin soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83033-0060 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 g in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g in 1 g METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g in 1 g SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) 1 g in 1 g EDETATE SODIUM (UNII: MP1J8420LU) 1 g in 1 g SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g in 1 g COCO DIETHANOLAMIDE (UNII: 92005F972D) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83033-0060-1 500 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/11/2022 ANTIBACTERIAL COOLING BREEZE
glycerin soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83033-0100 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 g in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g in 1 g METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g in 1 g SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) 1 g in 1 g EDETATE SODIUM (UNII: MP1J8420LU) 1 g in 1 g SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g in 1 g COCO DIETHANOLAMIDE (UNII: 92005F972D) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83033-0100-1 500 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/11/2022 ANTIBACTERIAL FRUITY ZEST
glycerin soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83033-0040 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 g in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g in 1 g METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g in 1 g SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) 1 g in 1 g EDETATE SODIUM (UNII: MP1J8420LU) 1 g in 1 g SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g in 1 g COCO DIETHANOLAMIDE (UNII: 92005F972D) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83033-0040-1 300 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/11/2022 ANTIBACTERIAL DELIGHTFUL SWEETNESS
glycerin soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83033-0080 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 g in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g in 1 g METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g in 1 g SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) 1 g in 1 g EDETATE SODIUM (UNII: MP1J8420LU) 1 g in 1 g SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g in 1 g COCO DIETHANOLAMIDE (UNII: 92005F972D) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83033-0080-1 500 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/11/2022 ANTIBACTERIAL DELIGHTFUL SWEETNESS
glycerin soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83033-0030 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 g in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g in 1 g METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g in 1 g SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) 1 g in 1 g EDETATE SODIUM (UNII: MP1J8420LU) 1 g in 1 g SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g in 1 g COCO DIETHANOLAMIDE (UNII: 92005F972D) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83033-0030-1 300 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/11/2022 ANTIBACTERIAL BOLD CITRUS
glycerin soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83033-0020 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 g in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g in 1 g METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g in 1 g SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) 1 g in 1 g EDETATE SODIUM (UNII: MP1J8420LU) 1 g in 1 g SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g in 1 g COCO DIETHANOLAMIDE (UNII: 92005F972D) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83033-0020-1 300 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/11/2022 ANTIBACTERIAL BOLD CITRUS
glycerin soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83033-0070 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 g in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 g in 1 g METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 1 g in 1 g SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) 1 g in 1 g EDETATE SODIUM (UNII: MP1J8420LU) 1 g in 1 g SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 1 g in 1 g COCO DIETHANOLAMIDE (UNII: 92005F972D) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83033-0070-1 500 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/11/2022 Labeler - Quimicas Handal de Centroamerica SA de CV (850638768) Registrant - Quimicas Handal de Centroamerica SA de CV (850638768) Establishment Name Address ID/FEI Business Operations Quimicas Handal de Centroamerica SA de CV 850638768 manufacture(83033-0010, 83033-0020, 83033-0030, 83033-0040, 83033-0050, 83033-0060, 83033-0070, 83033-0080, 83033-0090, 83033-0100) , label(83033-0010, 83033-0020, 83033-0030, 83033-0040, 83033-0050, 83033-0060, 83033-0070, 83033-0080, 83033-0090, 83033-0100)
