Label: PURE SAFER GEL(ETHANOL)- hand sanitizer gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 74142-201-50 - Packager: Sinbad 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 May 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
- Purpose
- Uses
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Inactive ingredients
- Directions:
- Other Information:
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
PURE SAFER GEL(ETHANOL)
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74142-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 65.6 mL in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE (UNII: V5VD430YW9) TOCOPHEROL (UNII: R0ZB2556P8) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74142-201-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/03/2020 Labeler - Sinbad Co.,Ltd (693900611) Registrant - Sinbad Co.,Ltd (693900611) Establishment Name Address ID/FEI Business Operations CAREPHARM 694639821 manufacture(74142-201)