Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
TOPCO ASSOCIATES LLC
TOPICAL
OTC DRUG
Antiseptic First aid to help prevent infection in minor cuts, scrapes and burns. deep or puncture wounds, animal bites, serious burns. The condition persists or gets worse, or if using this product for longer than 1 week.
OTC monograph not final
TOP CARE DECOLORIZED IODINE- ETHYL ALCOHOL LIQUID TOPCO ASSOCIATES LLC ---------- TOP CARE DECOLORIZED IODINE Drug Facts ACTIVE INGREDIENTS Alcohol 45 % denatured with ammonia, Ammonium and Potassium Iodides. PURPOSE Antiseptic USES First aid to help prevent infection in minor cuts, scrapes and burns. WARNINGS For external use only. ASK A DOCTOR BEFORE USE IF YOU HAVE deep or puncture wounds, animal bites, serious burns. STOP USE AND ASK A DOCTOR IF: The condition persists or gets worse, or if using this product for longer than 1 week. WHEN USING THIS PRODUCT: Do not use in the eyes. If contact occurs, flush with large amounts of water while lifting upper and lower lids. Do not apply over large areas of the body. KEEP OUT OF THE REACH OF CHILDREN. In case of acidental ingestion give milk, then give a starch solution made by mixing two tablespoonfools of cornstarch or flour to a pint of water. contact a poison Control Center immediately. DIRECTIONS Clean the affected area. Aply a small amount to the affected area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let it dry first. INACTIVE INGREDIENT: Purified Water PTHER INFORMATION: Will stain skin and clothing LABEL TOP CARE DECOLORIZED IODINE ethyl alcohol liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:36800-207 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.45 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH AMMONIA (UNII: 5138Q19F1X) IODINE (UNII: 9679TC07X4) POTASSIUM IODIDE (UNII: 1C4QK22F9J) WATER (UNII: 059QF0KO0R) TOPCO ASSOCIATES LLC PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:36800- 207-92 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/06/2017 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug M003 03/25/1998 LABELER - T Read the complete document