Label: DR. ALPHA HAND CLEANER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78146-756-10, 78146-756-11, 78146-756-12, 78146-756-30, view more78146-756-50, 78146-756-60 - Packager: EVESEL 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 January 9, 2021
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
DR. ALPHA HAND CLEANER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78146-756 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) 0.2 mL in 100 mL BUTANEDIOL (MIXED ISOMERS) (UNII: TMS4MGA0H4) 1 mL in 100 mL CARBOMER 980 (UNII: 4Q93RCW27E) 0.45 mL in 100 mL PANTHENOL (UNII: WV9CM0O67Z) 0.01 mL in 100 mL POLYSORBATE 60 (UNII: CAL22UVI4M) 0.05 mL in 100 mL WATER (UNII: 059QF0KO0R) 23.2 mL in 100 mL CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) 0.03 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78146-756-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/11/2020 2 NDC:78146-756-10 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/11/2020 3 NDC:78146-756-60 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/11/2020 4 NDC:78146-756-12 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/11/2020 5 NDC:78146-756-30 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/11/2020 6 NDC:78146-756-11 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/11/2020 Labeler - EVESEL CO., LTD (689533479) Establishment Name Address ID/FEI Business Operations EVESEL CO., LTD. 689533479 manufacture(78146-756)