Label: DR CLINIC ANTISEPTIC HAND GEL- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76725-011-01, 76725-011-02 - Packager: MAKYAJ KOZMETIK INSAAT SANAYI VE 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 September 10, 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 away from fire/flame. For external use only
Do not use
• in children less than 2 months of age • on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours - Directions
- Other information
- INACTIVE INGREDIENT
- Question? +1-800-686-5044
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
DR CLINIC ANTISEPTIC HAND GEL
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76725-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 73 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76725-011-01 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/10/2020 2 NDC:76725-011-02 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/10/2020 Labeler - MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI (504546402) Establishment Name Address ID/FEI Business Operations MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI 504546402 manufacture(76725-011)
