Label: YNBY- camphor, menthol, and methyl salicylate spray
- NDC Code(s): 61658-004-01, 61658-004-02
- Packager: YUNNAN BAIYAO GROUP CO., LTD.
- Category: HUMAN OTC DRUG LABEL
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 September 21, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
-
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
-
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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
YNBY
camphor, menthol, and methyl salicylate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61658-004 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:61658-004-01 1 in 1 BOX 09/21/2023 1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 2 NDC:61658-004-02 1 in 1 BOX 09/21/2023 2 85 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 not final part348 09/21/2023 Labeler - YUNNAN BAIYAO GROUP CO., LTD. (654223122) Establishment Name Address ID/FEI Business Operations YUNNAN BAIYAO GROUP CO., LTD. 654223122 manufacture(61658-004)