Label: 70% SAFETYPLUS HAND SANITIZER 32OZ- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80174-109-01 - Packager: SafetyPlus, 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 February 1, 2022
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- Active Ingredient
- Stop use and ask a doctor if skin irritation develops.
- Keep out of reach of children.
- Purpose : Antiseptic
- Questions ?
- Stop use and ask a doctor if skin irritation develops.
- When using this product section
- Directions section
- Other safety information
- Inactive ingredients
- Warnings section
- Dosage & Administration section
- Indications & Usage section
- Package front label
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INGREDIENTS AND APPEARANCE
70% SAFETYPLUS HAND SANITIZER 32OZ
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80174-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) 25.1 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 4 mL in 100 mL PANTHENOL (UNII: WV9CM0O67Z) 0.5 mL in 100 mL CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) 0.3 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.3 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80174-109-01 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/31/2020 Labeler - SafetyPlus, Inc. (122313405) Registrant - Orange Lab, Inc. (004862271) Establishment Name Address ID/FEI Business Operations Orange Lab, Inc 004862271 manufacture(80174-109)