Label: ALOESAFE ANTISEPTIC HAND SANITIZER- ethyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 12745-180-01, 12745-180-02, 12745-180-03 - Packager: Medical Chemical Corporation
- 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 17, 2022
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- Indications for Use
- Ingredients
- Ingredients
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Warnings
Warnings: Flammable, keep away from fire or flames. For external use on hands only. Avoid contact with face, eyes and broken skin. If this occurs, flush thoroughly with water. Discontinue use if irritation or redness develops. Keep out of reach of children. In case of ingestion contact Poison Control Center immediately.
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Warnings
Warnings: Flammable, keep away from fire or flames. For external use on hands only. Avoid contact with face, eyes and broken skin. If this occurs, flush thoroughly with water. Discontinue use if irritation or redness develops. Keep out of reach of children. In case of ingestion contact Poison Control Center immediately.
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Warnings
Warnings: Flammable, keep away from fire or flames. For external use on hands only. Avoid contact with face, eyes and broken skin. If this occurs, flush thoroughly with water. Discontinue use if irritation or redness develops. Keep out of reach of children. In case of ingestion contact Poison Control Center immediately.
- Directions
- Indications for use
- AloeSafe Label
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INGREDIENTS AND APPEARANCE
ALOESAFE ANTISEPTIC HAND SANITIZER
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12745-180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 60 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3) 0.25 g in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.2 g in 100 mL LAVENDER OIL (UNII: ZBP1YXW0H8) 0.02 g in 100 mL ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.04 g in 100 mL WATER (UNII: 059QF0KO0R) 28.03 g in 100 mL DIISOPROPYLAMINE (UNII: BR9JLI40NO) 0.2 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12745-180-01 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/14/2019 2 NDC:12745-180-02 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2010 3 NDC:12745-180-03 480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/01/2010 Labeler - Medical Chemical Corporation (008496861) Registrant - Medical Chemical Corporation (008496861) Establishment Name Address ID/FEI Business Operations Medical Chemical Corporation 008496861 manufacture(12745-180)
