Label: SERVCLEAN GEL HAND SANITIZER- alcohol gel
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NDC Code(s):
64646-380-02,
64646-380-03,
64646-380-04,
64646-380-12, view more64646-380-20, 64646-380-21, 64646-380-22, 64646-380-23
- Packager: Charlotte Products Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 22, 2024
If you are a consumer or patient please visit this version.
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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) (71%, 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).
- Distilled water.
- 2,4-D diethylethanolamine
- acrylates crosspolymer
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
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WHEN USING
When using this product keep out of 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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
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Package Label - Principal Display Panel
1250 mL NDC: 64646-380-04
500ml NDC:64646-380-12
2L NDC:64646-380-02
3.78 NDC:64646-380-03
18.9 L NDC:64646-380-20
55L NDC:64646-380-21
208L NDC:64646-380-22
1000L NDC:64646-380-23
1250 mL NDC: 64646-043-04
500 mL NDC:64646-043-12
2L NDC:64646-043-02
3.78L NDC:64646-043-03
18.9 L NDC: 64646-043-20
55 L NDC: 64646-043-21
208L NDC: 64646-043-22
1000L NDC: 64646-043-23
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INGREDIENTS AND APPEARANCE
SERVCLEAN GEL HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64646-380 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 71 mL in 100 mL Inactive Ingredients Ingredient Name Strength ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) 0.3 mL in 100 mL 2,4-D DIETHYLETHANOLAMINE (UNII: S070272I1T) 0.21 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.12 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64646-380-04 1250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/10/2021 2 NDC:64646-380-12 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/10/2021 3 NDC:64646-380-02 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/10/2021 4 NDC:64646-380-03 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/10/2021 5 NDC:64646-380-20 18900 mL in 1 PAIL; Type 0: Not a Combination Product 09/10/2021 6 NDC:64646-380-21 55000 mL in 1 DRUM; Type 0: Not a Combination Product 09/10/2021 7 NDC:64646-380-22 208000 mL in 1 DRUM; Type 0: Not a Combination Product 09/10/2021 8 NDC:64646-380-23 1000000 mL in 1 DRUM; Type 0: Not a Combination Product 09/10/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 09/10/2021 Labeler - Charlotte Products Ltd. (248293359) Establishment Name Address ID/FEI Business Operations Charlotte Products Ltd. 248293359 manufacture(64646-380)