Label: ANTIPERSPIRANT DRY 1.6 OZ LADY ANTIPERSPIRANT- aluminum chlorohydrate aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 57337-106-01 - Packager: Rejoice International Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 13, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
Flammable.
Do not spray near flame or while smoking.
Contents under pressure
Do not crush, puncture or incinerate container.
Do not expose to heat or store at temperatures above 120oF
Do not use on broken skin.
Ask a doctor before using, if you have kidney disease.
When using this product
Keep away from face and mouth to avoid breathing it. Avoid spraying in eyes.
Use only directed. Intentional missuse by deliberately concentrating and inhaling the contents can be harmful or fatal
Stop use if rash or irritation develops. - DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients
Isobutane, Butane, Hydrofluorocarbon 152a, Cyclopentasiloxane, Ethyl Alcohol, PPG-14 Butyl Ether, Helianthus Annuus Seed Oil, Isopropryl Myristate, C12-15 Alkyl Benzoate, Frangrance, Propane, Aluminum Starch Ocetenylsuccinate, Disteardimonium Hectorite, Dimethicone, Tocopheryl Acetate, BHT, Silica
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIPERSPIRANT DRY 1.6 OZ LADY ANTIPERSPIRANT
aluminum chlorohydrate aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M) ALUMINUM CHLOROHYDRATE 23.3 g in 100 g Inactive Ingredients Ingredient Name Strength ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PPG-14 BUTYL ETHER (UNII: R199TJT95T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ISOBUTANE (UNII: BXR49TP611) 1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0) SUNFLOWER OIL (UNII: 3W1JG795YI) PROPANE (UNII: T75W9911L6) LAURYL PHOSPHATE (UNII: 0K08L8GE2H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57337-106-01 45 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/13/2020 Labeler - Rejoice International Inc. (078741245) Establishment Name Address ID/FEI Business Operations Sanit & Sons Company Limited 660220096 manufacture(57337-106)
