Label: FRESH HAND ANTISEPTIC CLEANER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72257-250-00, 72257-250-01 - Packager: PROVINCE APOTHECARY 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 January 1, 2022
If you are a consumer or patient please visit this version.
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- DRUG FACTS
- ACTIVE INGREDIENT
- 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 wounds
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.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
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- FRESH GEL HAND ANTISEPTIC CLEANER 250 mL (NDC 72257-250-00)
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INGREDIENTS AND APPEARANCE
FRESH HAND ANTISEPTIC CLEANER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72257-250 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 60 mL in 100 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) LAURETH-7 (UNII: Z95S6G8201) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72257-250-01 1 in 1 BOX 05/28/2020 1 NDC:72257-250-00 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/28/2020 Labeler - PROVINCE APOTHECARY INC (201115232) Registrant - PROVINCE APOTHECARY INC (201115232)