Label: ACP HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78287-120-01, 78287-120-02, 78287-120-03, 78287-120-04, view more78287-120-05, 78287-120-06, 78287-120-07, 78287-120-08, 78287-120-09, 78287-120-10, 78287-120-11 - Packager: Swanrose, 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 26, 2020
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- Drug Facts
- Active Ingredient
- Purpose
- Uses
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Warnings
• For external use only. • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. • FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition. • Discontinue use if irritation or redness develops. • If irritation persists for more than 72 hours, consult a physician.
- Directions
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ACP HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78287-120 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78287-120-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/2020 2 NDC:78287-120-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/2020 3 NDC:78287-120-03 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/2020 4 NDC:78287-120-04 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/2020 5 NDC:78287-120-05 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/2020 6 NDC:78287-120-06 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/2020 7 NDC:78287-120-07 560 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/2020 8 NDC:78287-120-08 980 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/2020 9 NDC:78287-120-09 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/2020 10 NDC:78287-120-10 4000 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/24/2020 11 NDC:78287-120-11 5000 mL in 1 CAN; Type 0: Not a Combination Product 06/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/24/2020 Labeler - Swanrose, Inc. (117523391) Establishment Name Address ID/FEI Business Operations ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD 529558167 manufacture(78287-120)