Label: 70% DISPOSABLE DISINFECTANT GEL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75614-001-01, 75614-001-02, 75614-001-03, 75614-001-04, view more75614-001-05, 75614-001-06, 75614-001-07, 75614-001-08, 75614-001-09, 75614-001-10, 75614-001-11, 75614-001-12, 75614-001-13, 75614-001-14, 75614-001-15 - Packager: Guangzhou Pinshang Biotechnology Development Co.,Ltd.
- 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 3, 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
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
70% DISPOSABLE DISINFECTANT GEL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75614-001 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 ALOE (UNII: V5VD430YW9) 0.1 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 3 mL in 100 mL CARBOMER 980 (UNII: 4Q93RCW27E) 0.4 mL in 100 mL WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.5 mL in 100 mL AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 0.08 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75614-001-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 2 NDC:75614-001-02 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 3 NDC:75614-001-03 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 4 NDC:75614-001-05 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 5 NDC:75614-001-04 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 6 NDC:75614-001-06 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 7 NDC:75614-001-07 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 8 NDC:75614-001-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 9 NDC:75614-001-09 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 10 NDC:75614-001-10 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 11 NDC:75614-001-11 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 12 NDC:75614-001-12 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 13 NDC:75614-001-13 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 14 NDC:75614-001-14 3800 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 15 NDC:75614-001-15 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/31/2020 Labeler - Guangzhou Pinshang Biotechnology Development Co.,Ltd. (554530020) Registrant - Guangzhou Pinshang Biotechnology Development Co.,Ltd. (554530020) Establishment Name Address ID/FEI Business Operations Guangzhou Pinshang Biotechnology Development Co.,Ltd. 554530020 manufacture(75614-001)