BEE BRAND MEDICATED- menthol and camphor oil 
PT. TAWON JAYA MAKASSAR

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.

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Drug Facts

Active ingredients
Menthol 2.2%
Camphor 4%

Purpose
External analgesic
External analgesic

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
■ simple backache
■ arthritis
■ strains
■ bruises
■ sprains

Warnings
For external use only

Do not use
■ on wounds
■ on irritated or damaged skin
■ if excessive irritation develops
■ over extensive parts of the body
■ if you are allergic to any ingredients in this product

When using this product 

■ avoid contact with the eyes or mucous membranes

■ do not bandage tightly

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 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 to affected area with cotton 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 protected from light at 15 to 30 C (59 to 86 F)

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 or comments? (888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number

BEE BRAND MEDICATED OIL

NDC 66525-056-01

EXTERNAL ANALGESIC

3 FL OZ (90 mL)
IMAGE OF BOX

BEE BRAND MEDICATED OIL

NDC 66525-056-02

EXTERNAL ANALGESIC

2 FL OZ (60 mL)

IMAGE OF BOX

BEE BRAND MEDICATED 
menthol and camphor oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66525-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.2 mg  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66525-056-011 in 1 BOX06/03/2021
190 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2NDC:66525-056-021 in 1 BOX06/30/2021
260 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/03/2021
Labeler - PT. TAWON JAYA MAKASSAR (726639268)
Establishment
NameAddressID/FEIBusiness Operations
PT. TAWON JAYA MAKASSAR726639268manufacture(66525-056)

Revised: 6/2021
Document Id: 08674efa-99b1-4f65-9a69-3cda3a12a856
Set id: 7b0a6bf5-d63b-452d-8b58-d6199bb7baa3
Version: 2
Effective Time: 20210630
 
PT. TAWON JAYA MAKASSAR