YNBY- camphor, menthol, and methyl salicylate spray 
YUNNAN BAIYAO GROUP CO., LTD.

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
Camphor 3.5%
Menthol 4.5%
Methyl Salicylate10%

Purpose
External analgesic
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
Flammable: keep away from fire or flame

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

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 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 to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

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

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

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

YNBY SPRAY

External Analgesic

NDC 61658-004-01

1 fl oz (30 mL)

IMAGE OF 30ML BOX

YNBY SPRAY

External Analgesic

NDC 61658-004-02

2.9 fl oz (85 mL)

IMAGE OF 85ML BOX

YNBY 
camphor, menthol, and methyl salicylate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61658-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.5 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.5 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61658-004-011 in 1 BOX09/21/2023
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC:61658-004-021 in 1 BOX09/21/2023
285 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/21/2023
Labeler - YUNNAN BAIYAO GROUP CO., LTD. (654223122)
Establishment
NameAddressID/FEIBusiness Operations
YUNNAN BAIYAO GROUP CO., LTD.654223122manufacture(61658-004)

Revised: 9/2023
Document Id: adb4475a-691d-4c01-8a23-b8088079f335
Set id: fd781097-7283-4d4c-bc57-5946692231ca
Version: 1
Effective Time: 20230921
 
YUNNAN BAIYAO GROUP CO., LTD.