Label: ALLPURE HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78575-002-01, 78575-002-02, 78575-002-03, 78575-002-04, view more78575-002-05, 78575-002-06, 78575-002-07 - Packager: YESILILGAZ KOZMETIK KIMYA INSAAT OTOMOTIV VE GIDA SANAYI TICARET LIMITED SIRKETI
- 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 July 8, 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
- Use
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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 products 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
- Directions
- Other information
- Inactive ingredients
- Product label
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INGREDIENTS AND APPEARANCE
ALLPURE HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78575-002 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) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) ROSEMARY (UNII: IJ67X351P9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78575-002-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/20/2020 2 NDC:78575-002-02 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/20/2020 3 NDC:78575-002-03 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/20/2020 4 NDC:78575-002-04 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/20/2020 5 NDC:78575-002-05 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/20/2020 6 NDC:78575-002-06 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/20/2020 7 NDC:78575-002-07 5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/20/2020 Labeler - YESILILGAZ KOZMETIK KIMYA INSAAT OTOMOTIV VE GIDA SANAYI TICARET LIMITED SIRKETI (355436838) Establishment Name Address ID/FEI Business Operations YESILILGAZ KOZMETIK KIMYA INSAAT OTOMOTIV VE GIDA SANAYI TICARET LIMITED SIRKETI 355436838 manufacture(78575-002)
