Label: SPARKLE- isopropyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78541-1001-2 - Packager: NBA General Corporation 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 September 18, 2020
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- Directions
- Other information
- Inactive ingredients
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SPARKLE
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78541-1001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) 2.5 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.95 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL WATER (UNII: 059QF0KO0R) 24.6 mL in 100 mL FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.5 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78541-1001-2 1893 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - NBA General Corporation INC (043707019) Establishment Name Address ID/FEI Business Operations NBA General Corporation INC 043707019 manufacture(78541-1001)