Label: BEE BRAND MEDICATED- menthol and camphor oil
- NDC Code(s): 66525-056-01, 66525-056-02
- Packager: PT. TAWON JAYA MAKASSAR
- 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 June 30, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
-
STOP USE
Stop use and ask a doctor if
■ condition worsens
■ symptoms clear up and occur again within a few days
■ symptoms persist for more than 7 days
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ when using for pain of arthritis if:
■ in conditions affecting children under 12 years of age
■ redness is present
■ pain persists for more than 10 days - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
Achyranthes root, boesenbergia rotunda root, burpleurum falcatum root, cajuput oil, ceylon citronella root, cinnamomum culilawan leaf oil, coconut oil, garlic bulb, ginger root, greater galangal root, hance pepper aerial parts, onion bulb, pepper root, pubescent angelica root, Saigon cinnamon, turmeric root, turpentine oil, and West Indian lemongrass oil. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BEE BRAND MEDICATED
menthol and camphor oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66525-056 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.2 mg in 100 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 4 mg in 100 mL Inactive Ingredients Ingredient Name Strength ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1) BOESENBERGIA ROTUNDA ROOT (UNII: J7TKP1SS3G) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) CAJUPUT OIL (UNII: J3TO6BUQ37) CYMBOPOGON NARDUS WHOLE (UNII: A9TR1GFH5L) CINNAMOMUM CULILABAN LEAF OIL (UNII: HAG3U9ZKA6) COCONUT OIL (UNII: Q9L0O73W7L) GARLIC (UNII: V1V998DC17) GINGER (UNII: C5529G5JPQ) GREATER GALANGAL (UNII: 7Y64R856MB) PIPER HANCEI TOP (UNII: AMU868N7QW) ONION (UNII: 492225Q21H) PIPER NIGRUM WHOLE (UNII: 49L10LI8DN) ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ) CINNAMOMUM LOUREIROI WHOLE (UNII: 7N878U293P) TURMERIC (UNII: 856YO1Z64F) TURPENTINE OIL (UNII: C5H0QJ6V7F) CITRONELLA OIL (UNII: QYO8Q067D0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66525-056-01 1 in 1 BOX 06/03/2021 1 90 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 2 NDC:66525-056-02 1 in 1 BOX 06/30/2021 2 60 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/03/2021 Labeler - PT. TAWON JAYA MAKASSAR (726639268) Establishment Name Address ID/FEI Business Operations PT. TAWON JAYA MAKASSAR 726639268 manufacture(66525-056)