Label: BBL ADVANCED HAND SANITIZER REFRESHING- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78579-010-01 - Packager: Boston Biolabs. 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 June 8, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
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WARNINGS
For external use only. Flammable. Keep away from fire or flame.
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Do not use
• in children less than 2 months of age.
• on open skin wounds.
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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
- Uses
- Directions
- Other information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BBL ADVANCED HAND SANITIZER REFRESHING
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78579-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 350 g in 500 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) LAVENDER OIL (UNII: ZBP1YXW0H8) Butylene Glycol (UNII: 3XUS85K0RA) Hexylene Glycol (UNII: KEH0A3F75J) BEACH STRAWBERRY (UNII: 98542F2TQS) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78579-010-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/01/2020 Labeler - Boston Biolabs. Inc. (695890000) Registrant - Boston Biolabs. Inc. (695890000) Establishment Name Address ID/FEI Business Operations DongbangCosmetics Co., ltd. 694452564 manufacture(78579-010)