WONG LOP KONG MEDICATED- camphor oil WONG LAP KWONG MEDICINE COMPANY LIMITED 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 Camphor 4% Purpose External analgesic Uses For the temporary relief of minor aches and pains of muscles and joints due to: simple backache, arthritis, strains, bruises, sprai Warnings For external use only Allergy alert: Discontinue if irritation or rash appears. Prolonged or frequent skin contact may cause allergic reactions in some individuals. Do not use on wounds, on damaged skin When using this product avoid contact with the eyes do not bandage tightly Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away. Directions Adults and children 2 years of age and older: Apply a few drops to the affected area and rub gently not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a doctor. Other information keep container tightly closed store at 15E to 30 C (59 to 86 F) Inactive ingredients Camphor Oil, Dong-Quai root, Dragon’s Blood resin, Eucalyptus Oil, Fragrant Angelica Root, Frankincense gum resin, Field Mint herb, Myrrh gum resin, Oil of Citronella, Peppermint Oil, Pine resin, Red-Rooted Sage root, Safflower flower, Sichuan Lovage rhizome, Tea Oil Questions or comments? (888) 221-3496 M-F 9 am to 5 pm WONG LOP KONG MEDICATED OIL, External Analgesic, NDC 54188–003-01, 1 fl oz (30 mL) WONG LOP KONG MEDICATED camphor oil Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:5418 8 -0 0 3 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHO R (SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) - CAMPHOR 4 g UNII:5TJD8 2A1ET) (SYNTHETIC) in 10 0 mL Inactive Ingredients Ingredient Name Strength CAMPHO R O IL (UNII: 75IZZ8 Y727) ANGELICA SINENSIS RO O T (UNII: B6 6 F4574UG) DRAGO N'S BLO O D (UNII: M3YJ2C28 IC) EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2) ANGELICA DAHURICA RO O T (UNII: 1V6 3N2S9 72) FRANKINCENSE (UNII: R9 XLF1R1WM) MENTHA ARVENSIS WHO LE (UNII: 46 477RRB3O) MYRRH (UNII: JC71GJ1F3L) CITRO NELLA O IL (UNII: QYO8 Q0 6 7D0 ) PEPPERMINT O IL (UNII: AV0 9 2KU4JH) PINUS MASSO NIANA RESIN (UNII: 6 4S0 7U8 3T7) SALVIA O FFICINALIS RO O T (UNII: 236 QY0 A1BL) SAFFLO WER (UNII: 4VBL71TY4Y) LIGUSTICUM SINENSE SUBSP. CHUANXIO NG WHO LE (UNII: CAX256 379 F) CAMELLIA O LEIFERA WHO LE (UNII: 1C0 QTA6 1GT) Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:5418 8 -0 0 3- 1 1 in 1 BOX 0 3/29 /20 0 4 0 1 30 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n 1 Pro duct Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part348 0 3/29 /20 0 4 Labeler - WONG LAP KWONG MEDICINE COMPANY LIMIT ED (686530791) Establishment Name Addre ss ID/FEI Busine ss Ope rations WONG LAP KWONG MEDICINE COMPANY LIMITED 6 8 6 530 79 1 manufacture(5418 8 -0 0 3) Revised: 11/2019 WONG LAP KWONG MEDICINE COMPANY LIMITED.