YUNNAN BAIYAO- camphor, menthol, and methyl salicylate spray

Yunnan Baiyao by

Drug Labeling and Warnings

Yunnan Baiyao by is a Otc medication manufactured, distributed, or labeled by YUNNAN BAIYAO GROUP CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Camphor 3.5%
Menthol 4.5%
Methyl Salicylate10%

PURPOSE

Purpose
External analgesic
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
Flammable: keep away from fire or flame

DO NOT USE

Do not use
on irritated or damaged skin
on wounds
otherwise than as directed

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 persist for more than 7 days
symptoms clear up and occur again within a few days
excessive irritation of the skin develops
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
when using for pain of arthritis:
     pain persists for more than 10 days
     redness is present
     in conditions affecting children under 12 years of age

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
shake well before using
adults and children 3 years of age and older: remove the attached film from the patch. Apply to affected area not more than 3 to 4 times daily
children under 3 years of age: do not use, consult your physicianrefer to the above warnings; use otherwise than as directed may be dangerous

STORAGE AND HANDLING

Other information
keep tightly closed
store at 15 to 30 C (59 to 86 F)

INACTIVE INGREDIENT

Inactive ingredients
Alcohol, ampelopsis delavayana root, capsicum, Chinese yam rhizome, corydalis yanhusuo rhizome, dong-quai root, fragrant angelica root, Japanese dioscorea rhizome, san-qi ginseng root and rhizome, Sichuan lovage rhizome.

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

Yunnan Baiyao SPRAY

External Analgesic

NDC: 61658-006-01

1 fl oz (30 mL)

PRINCIPAL DISPLAY PANEL

Yunnan Baiyao SPRAY

External Analgesic

NDC: 61658-006-02

2.9 fl oz (85 mL)

PRINCIPAL DISPLAY PANEL

Yunnan Baiyao SPRAY

External Analgesic

NDC: 61658-006-03

1.7 fl oz (50 mL)

INGREDIENTS AND APPEARANCE

YUNNAN BAIYAO 
camphor, menthol, and methyl salicylate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61658-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.5 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.5 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMPELOPSIS DELAVAYANA ROOT (UNII: N93790DMR5)
CAPSICUM (UNII: 00UK7646FG)
CHINESE YAM (UNII: 29CIF30B1Z)
CORYDALIS YANHUSUO WHOLE (UNII: DX4V4VDT5J)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
DIOSCOREA JAPONICA WHOLE (UNII: 1I0396UIN0)
PANAX NOTOGINSENG WHOLE (UNII: E7XOU43ESD)
LIGUSTICUM SINENSE SUBSP. CHUANXIONG WHOLE (UNII: CAX256379F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61658-006-01	1 in 1 BOX	03/19/2024
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 61658-006-02	1 in 1 BOX	03/19/2024
2		85 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC: 61658-006-03	1 in 1 BOX	05/10/2024
3		50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	part348	03/19/2024

Labeler - YUNNAN BAIYAO GROUP CO., LTD. (654223122)

Establishment
Name	Address	ID/FEI	Business Operations
YUNNAN BAIYAO GROUP CO., LTD.		654223122	manufacture(61658-006)