BEE BRAND MEDICATED- menthol and camphor oil

BEE BRAND MEDICATED by

Drug Labeling and Warnings

BEE BRAND MEDICATED by is a Otc medication manufactured, distributed, or labeled by PT. TAWON JAYA MAKASSAR. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Menthol 2.2%
Camphor 4%

PURPOSE

Purpose
External analgesic
External analgesic

INDICATIONS & USAGE

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

WARNINGS

Warnings
For external use only

DO NOT USE

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

When using this product 

■ avoid contact with the eyes or mucous membranes

■ do not bandage tightly

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

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other information
■ keep container tightly closed

■ store protected from light at 15 to 30 C (59 to 86 F)

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

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

PRINCIPAL DISPLAY PANEL

BEE BRAND MEDICATED OIL

NDC: 66525-056-01

EXTERNAL ANALGESIC

3 FL OZ (90 mL)

PRINCIPAL DISPLAY PANEL

BEE BRAND MEDICATED OIL

NDC: 66525-056-02

EXTERNAL ANALGESIC

2 FL OZ (60 mL)

INGREDIENTS AND APPEARANCE

BEE BRAND MEDICATED 
menthol and camphor oil

Product 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)