Label: ROLHEI 75 PERCENT ETHANOL WET WIPE- alcohol cloth
-
Contains inactivated NDC Code(s)
NDC Code(s): 78580-010-01 - Packager: Glory Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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 16, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
-
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
- Uses
- Directions
- Other information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ROLHEI 75 PERCENT ETHANOL WET WIPE
alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78580-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 in 100 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) Glycerin (UNII: PDC6A3C0OX) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78580-010-01 100 in 1 PACKET; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/01/2020 Labeler - Glory Co., Ltd. (688492036) Registrant - Glory Co., Ltd. (688492036) Establishment Name Address ID/FEI Business Operations Glory Co., Ltd. 688492036 manufacture(78580-010)