Label: AUTOSPRITZ- alcohol solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 79281-010-01, 79281-010-02 - Packager: ORIGYN LLC
- 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 July 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- INACTIVE INGREDIENTS
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
- For external use only. Flammable. Keep away from heat or flame.
- Do not use
- for 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 of rash occurs. These may be signs of a serious health condition.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- Refill Bottle 33.8 fl oz (1L)
- Auto Dispenser Bottle 12 fl oz (355ml)
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INGREDIENTS AND APPEARANCE
AUTOSPRITZ
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79281-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 L in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 L in 100 L HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L in 100 L WATER (UNII: 059QF0KO0R) 18.425 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79281-010-01 1 L in 1 BOTTLE; Type 0: Not a Combination Product 07/02/2020 2 NDC:79281-010-02 0.355 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 07/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/02/2020 Labeler - ORIGYN LLC (117542954) Establishment Name Address ID/FEI Business Operations Guangzhou Shiruoni Cosmetics Co. Ltd 551125378 manufacture(79281-010)
