Label: EVELINECHARLES PURE PURIFYING HAND CREAM MAX- alcohol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76555-007-01 - Packager: EC Labs 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 October 28, 2021
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
EVELINECHARLES PURE PURIFYING HAND CREAM MAX
alcohol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76555-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 37.8 g in 60 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.29 g in 60 g PEG/PPG-18/12 DIMETHICONE (UNII: 2AY8NFX9E4) 5.1 g in 60 g WATER (UNII: 059QF0KO0R) 13.14 g in 60 g SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G) 1.74 g in 60 g AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) 0.79 g in 60 g TOCOPHEROL (UNII: R0ZB2556P8) 0.06 g in 60 g 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) 0.0012 g in 60 g 3-CARENE (UNII: H2M15SNR6N) 0.0012 g in 60 g DIHYDROMYRCENOL (MIXED ISOMERS) (UNII: 7E6BIK8N98) 0.0036 g in 60 g ETHYL LINALOOL (UNII: SF2JS9GF5T) 0.0012 g in 60 g CEDRAMBER (UNII: 84S7T555CV) 0.0012 g in 60 g CYMENE (UNII: 830CI19HHD) 0.0012 g in 60 g LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.0012 g in 60 g CYCLOMETHICONE (UNII: NMQ347994Z) 1.02 g in 60 g TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE) 0.0072 g in 60 g .BETA.-PINENE (UNII: 4MS8VHZ1HJ) 0.0012 g in 60 g GERANIOL (UNII: L837108USY) 0.0012 g in 60 g METHYL IONONES (UNII: EL78BGX1LO) 0.0012 g in 60 g .ALPHA.-PINENE (UNII: JPF3YI7O34) 0.0012 g in 60 g PENTADECALACTONE (UNII: OK17S3S98K) 0.0012 g in 60 g BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.0024 g in 60 g DIHYDRO PENTAMETHYLINDANONE (UNII: BZR4438MY4) 0.0024 g in 60 g COUMARIN (UNII: A4VZ22K1WT) 0.0012 g in 60 g LINALYL ACETATE (UNII: 5K47SSQ51G) 0.0024 g in 60 g BOURGEONAL (UNII: H3XVS6E70V) 0.0012 g in 60 g 2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913) 0.0024 g in 60 g LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.0024 g in 60 g .GAMMA.-TERPINENE (UNII: 4YGF4PQP49) 0.0012 g in 60 g METHYL 3-METHYLORSELLINATE (UNII: 12YH9T04QE) 0.0012 g in 60 g ALLYL CYCLOHEXANEBUTYRATE (UNII: 9JIF47RD7B) 0.0012 g in 60 g .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) 0.0012 g in 60 g 3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA) 0.0024 g in 60 g AMBREIN (UNII: 1N9JB373FJ) 0.0012 g in 60 g CYCLOHEXANEPROPANOL, 2,2,6-TRIMETHYL-.ALPHA.-PROPYL- (UNII: CLV4EM4325) 0.0012 g in 60 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76555-007-01 60 g in 1 TUBE; Type 0: Not a Combination Product 10/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/28/2021 Labeler - EC Labs Inc. (205510751) Registrant - EC Labs Inc. (205510751) Establishment Name Address ID/FEI Business Operations EC Labs Inc. 205510751 manufacture(76555-007) , pack(76555-007) , label(76555-007)
60g NDC: 76555-007-01