DOMEBORO - aluminum s ulfate tetradecahydrate, calcium acetate monohydrate powder, for s olution Advantice Health, LLC. 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 Facts Active Ingredients (in each packet) Purpose Aluminum sulfate tetradecahydrate, 1347 mg Astringent* Calcium acetate monohydrate, 952 mg Astringent* *When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions. Uses temporarily relieves minor skin irritations due to: poison ivy poison oak poison sumac insect bites athlete's foot rashes caused by soaps, detergents, cosmetics, or jewelry Warnings For external us e only When us ing this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. do not cover compress or wet dressing with plastic to prevent evaporation in some skin conditions, soaking too long may overdry Stop us e and as k a doctor if condition worsens or symptoms persist for more than 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions dissolve 1 to 3 packets in a pint (16 oz) of cool or warm water stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.16% (1 packet), 0.32% (2 packets), or 0.48% (3 packets) aluminum acetate and is ready for use. For us e as a s oak: soak affected area for 15 to 30 minutes as needed, or as directed by a doctor repeat 3 times a day or as directed by a doctor discard solution after each use For us e as a compres s or wet dres s ing: soak a clean, soft cloth in the solution apply cloth loosely to affected area for 15 to 30 minutes repeat as needed or as directed by a doctor discard solution after each use Other information protect from excessive heat Inactive ingredients dextrin Ques tions or comments ? 1-800-345-0032 www.domeboro.com Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927 PRINCIPAL DISPLAY PANEL - 12 Packet Box DOCTOR RECOMMENDED DOMEBORO Aluminum Sulfate Tetradecahydrate / Calcium Acetate Monohydrate-Astringent Burow's Solution Relief Since 1958 CALMING & SOOTHING Medicated Soak RASH RELIEF PLUS DRYING ACTION EFFECTIVE FOR POISON IVY, OAK, SUMAC & OTHER RASHES Dries Oozing Rashes Relieves Itching & Burning Reduces Blistering 12 POWDER PACKETS RELIEF AT LAST NET WT 0.1 OZ (2.7 G) EACH ® DOMEBORO Advantice Health, LLC. aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution Product Information Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:16 8 6 4-240 Route of Ad minis tration TO PICAL Active Ing redient/Active Moiety Ing redient Name Basis o f Streng th Streng th ALUMINUM SULFATE TETRADECAHYDRATE (UNII: E3UT6 6 50 4P) (ALUMINUM CATIO N - UNII:3XHB1D0 32B) ALUMINUM SULFATE TETRADECAHYDRATE 1347 mg Ca lc ium Ac e ta te Mo no hydra te (UNII: 7ZA48 GIM5H) (Ac e ta te Io n - UNII:56 9 DQ M74SC) Ca lc ium Ac e ta te Mo no hydra te 9 52 mg Inactive Ing redients Ing redient Name Streng th Ic o de xtrin (UNII: 2NX48 Z0 A9 G) Product Characteristics Color WHITE S core S hap e S iz e Flavor Imp rint Cod e Contains Packag ing # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date 1 NDC:16 8 6 4-240 -0 1 12 in 1 BO X; Type 0 : No t a Co mbina tio n Pro duc t 0 6 /26 /20 12 2 NDC:16 8 6 4-240 -10 10 0 in 1 BO X; Type 0 : No t a Co mbina tio n Pro duc t 0 6 /26 /20 12 0 4/30 /20 17 3 NDC:16 8 6 4-240 -14 14 in 1 BO X; Type 0 : No t a Co mbina tio n Pro duc t 0 6 /26 /20 12 0 7/31/20 18 Marketing Information Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date O TC mo no gra ph no t fina l pa rt347 0 6 /26 /20 12 Labeler - Advantice Health, LLC. (192527062) Revised: 1/2020