Label: DETRODERM SOFT GEL HAND AND SKIN ANTISEPTIC- alcohol gel
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NDC Code(s):
79506-103-01,
79506-103-02,
79506-103-03,
79506-103-04, view more79506-103-05, 79506-103-06
- Packager: DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI
- 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 April 20, 2021
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)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
Flammable. Keep out of ignition sources directly.
Do not use
Before reading user manual
After 6 months from cover opening
When using this product
No smoking. must not be contacted with powerful oxidants, alkali metals due to fire and explosion possibility. Keep out of reach of children, food and animal foods. Keep out of ignition sources directly. Do not stock with oxidant and spontaneously combustible materials. Obey instructions existed in user manual.
Stop use and ask a doctor if
*In case of poisoning
*In case of ingestion
*In case of contact with eyes
- Directions
- Other Information
- Inactive ingredients
- Questions
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SPL UNCLASSIFIED SECTION
• Wide Effect Spectrum
• Alcohol Based
• Extensive Skin Compatibility
• Usable at Dispenser
Email: international@detrox.com.tr
MADE IN TURKEY
detrox®
Integrated Disinfection Solutions
Producer Name and Address:
Detro Healthcare Kimya Sanayi A.S.
Ataturk mh. Adnan Menderec cd.
No:7 Esenyurt/Istanbul-Turkey
- Packaging
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INGREDIENTS AND APPEARANCE
DETRODERM SOFT GEL HAND AND SKIN ANTISEPTIC
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79506-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79506-103-01 5000 mL in 1 CONTAINER; Type 0: Not a Combination Product 04/15/2021 2 NDC:79506-103-02 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2021 3 NDC:79506-103-03 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2021 4 NDC:79506-103-04 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2021 5 NDC:79506-103-05 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2021 6 NDC:79506-103-06 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/15/2021 Labeler - DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI (533133207) Establishment Name Address ID/FEI Business Operations DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI 533133207 manufacture(79506-103)