BELLADONA- methyl salicylate, menthol ointment 
Miramar Cosmetics, Inc DBA Miramar Lab

----------

Belladona

Drug Facts

Active Ingredients

Methyl Salicylate 10%
Menthol 3.5%

Purpose

Topical Analgesic

Uses:

*Helps relieve minor aches and pain of muscles, joints, strains, backache, sprains, and sport injuries.

Warnings:

For external use only.

Do not Use:
• If allergic to salicylates (including aspirin) without consulting a physician.
• On open wounds, damage or irritated skin, immediately after or before taking a shower.

Stop use and ask a Doctor: If conditions worsen, symptoms persist or skin irritations occurs.

When using this product: Avoid contact with eyes, lips and any mucous membranes.

Keep out of reach of children. 
If swallowed get medical help. Do not bandage.

Directions:

Clean area before use.
Adults & Children 12 years of age or older: Apply to affected area no more than 3 times daily. Temporary burning may be felt when applied, but disappears with continued use.
Wash hands after used. If applying liniment to the hands wait 30 minutes before washing hands. Initial pain relief is noted within 1-2 weeks.

Children under 12 years: Consult a Physician before use.

Other Information:

Store at 15-25° C (59-77° F)

Inactive Ingredients:

White Petrolatum, Soybean Oil, Belladonna extract, Green MX-144A.

MADE IN USA
SATISFACTION GUARANTEED QUALITY

*These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure or prevent any disease.

Distributed by:
OTC & Quality Products
Orlando, FL 32837

InfoLine:
1-877-325-7887

www.otcqualityproducts.com

Packaging

Miramar-209

BELLADONA 
methyl salicylate, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79974-209
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
SOYBEAN OIL (UNII: 241ATL177A)  
BELLADONNA LEAF (UNII: 6GZW20TIOI)  
D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79974-209-05150 g in 1 JAR; Type 0: Not a Combination Product01/08/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/08/2024
Labeler - Miramar Cosmetics, Inc DBA Miramar Lab (012873243)
Establishment
NameAddressID/FEIBusiness Operations
Miramar Cosmetics, Inc DBA Miramar Lab012873243manufacture(79974-209)

Revised: 12/2023
Document Id: e92570a4-d837-4201-8153-1a9796126820
Set id: 092c06e1-aa6c-4ed3-af46-d28ece37f6a0
Version: 1
Effective Time: 20231220
 
Miramar Cosmetics, Inc DBA Miramar Lab