Label: ARMOUR HAND AND SKIN SANITIZER- ethyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78087-001-01, 78087-001-02, 78087-001-05, 78087-001-10 - Packager: SOZAL KIMYA SANAYI VE TICARET 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 May 29, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient[s]
- Purpose
- Uses[s]
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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 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.
- Directions
- Other information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ARMOUR HAND AND SKIN SANITIZER
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78087-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.8 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78087-001-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 2 NDC:78087-001-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 3 NDC:78087-001-05 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 4 NDC:78087-001-10 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/29/2020 Labeler - SOZAL KIMYA SANAYI VE TICARET ANONIM SIRKETI (355628049) Establishment Name Address ID/FEI Business Operations SOZAL KIMYA SANAYI VE TICARET ANONIM SIRKETI 355628049 manufacture(78087-001)
