Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74220-003-01, 74220-003-02, 74220-003-03, 74220-003-04, view more74220-003-05, 74220-003-06, 74220-003-07, 74220-003-08, 74220-003-09, 74220-003-10, 74220-003-11, 74220-003-17 - Packager: Super Dope Laboratories 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 June 25, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
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. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74220-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) HYDROGEN PEROXIDE (UNII: BBX060AN9V) LINALOOL, (+/-)- (UNII: D81QY6I88E) TROLAMINE (UNII: 9O3K93S3TK) LAVENDER OIL (UNII: ZBP1YXW0H8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74220-003-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:74220-003-03 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 3 NDC:74220-003-04 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 4 NDC:74220-003-05 750 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 5 NDC:74220-003-06 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 6 NDC:74220-003-17 100 in 1 BOX 03/30/2020 6 NDC:74220-003-07 2 mL in 1 PACKET; Type 0: Not a Combination Product 7 NDC:74220-003-02 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 8 NDC:74220-003-08 3790 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 9 NDC:74220-003-09 1419528.75 mL in 1 DRUM; Type 0: Not a Combination Product 03/30/2020 10 NDC:74220-003-10 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11 NDC:74220-003-11 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Super Dope Laboratories LLC (055650002) Establishment Name Address ID/FEI Business Operations Super Dope Laboratories LLC 055650002 manufacture(74220-003) , label(74220-003) , pack(74220-003)
