Label: DETROX - DETRODERM HAND AND SKIN ANTISEPTIC- isopropyl alcohol liquid
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NDC Code(s):
79506-100-01,
79506-100-02,
79506-100-03,
79506-100-04, view more79506-100-05
- Packager: DETRO HEALTHCARE KIMYA SANAYI ANONIM 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 24, 2020
If you are a consumer or patient 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
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
DETROX - DETRODERM HAND AND SKIN ANTISEPTIC
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79506-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79506-100-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 2 NDC:79506-100-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 3 NDC:79506-100-03 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 4 NDC:79506-100-04 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2020 5 NDC:79506-100-05 5000 mL in 1 CAN; Type 0: Not a Combination Product 06/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/30/2020 Labeler - DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI (533133207) Establishment Name Address ID/FEI Business Operations DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI 533133207 manufacture(79506-100)