Label: CORNELLS- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78117-002-01, 78117-002-02 - Packager: Premier Cosmetics
- 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 2, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
in 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 or rash occurs. These may be signs of a serious condition.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
CORNELLS
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78117-002 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78117-002-01 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/02/2020 2 NDC:78117-002-02 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/02/2020 Labeler - Premier Cosmetics (557941540) Establishment Name Address ID/FEI Business Operations Premier Cosmetics 557941540 manufacture(78117-002)