SOLSTICE PAIN RELIEVING- camphor, menthol, methyl salicylate patch

Solstice Pain Relieving by

Drug Labeling and Warnings

Solstice Pain Relieving by is a Otc medication manufactured, distributed, or labeled by MADISON ONE ACME INC, Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Camphor 3.1%
Menthol 6.0%
Methyl salicylate 10.0%

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

DO NOT USE

Do not use
on irritated or damaged skin on wounds

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you have
any concerns about using this product

WHEN USING

When using this product

• avoid contact with the eyes or mucous membranes
• 
do not bandage tightly

• do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

• avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

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
• 
you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

• 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

ADVERSE REACTIONS

Report any unexpected side effects from the use of this product to the FDA MedWatch Program

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• adults and children 3 years of age and older:
  
  • clean and dry affected area
  • remove the protective film from the patch
  • apply patch to affected area not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application
  • wet patch with warm water before removing from the skin


• children under 3 years of age: consult your physician

STORAGE AND HANDLING

Other information

• keep patches tightly closed in the zip-lock pouch
• avoid excessive heat

INACTIVE INGREDIENT

Inactive ingredientshydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, and styrene/isoprene copolymer.

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

Solstice Pain Relieving Patch

Camphor 3.1%, Menthol 6.0%, Methyl Salicylate 10%

NDC: 55614-210-20

20 Patches, Each Patch 2.83 in x 1.81 in (7.2 cm x 4.6 cm)

PRINCIPAL DISPLAY PANEL

Solstice Pain Relieving Patch

Camphor 3.1%, Menthol 6.0%, Methyl Salicylate 10%

NDC: 55614-210-60

60 Patches in 3 Pouches, 20 Patches per Pouch
Each Patch 2.83 in x 1.81 in (7.2 cm x 4.6 cm)

PRINCIPAL DISPLAY PANEL

Solstice Pain Relieving Patch

Camphor 3.1%, Menthol 6.0%, Methyl Salicylate 10%

NDC: 55614-210-02

2 Patches, Each Patch 2.83 in x 1.81 in (7.2 cm x 4.6 cm)

Sample Only / Not For Re-Sale

INGREDIENTS AND APPEARANCE

SOLSTICE PAIN RELIEVING 
camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55614-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55614-210-20	20 in 1 BOX	07/26/2019
1		9 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 55614-210-60	60 in 1 BOX	07/26/2019
2		9 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 55614-210-02	2 in 1 POUCH	07/26/2019
3		9 g in 1 PATCH; 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	07/26/2019

Labeler - MADISON ONE ACME INC (096196758)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(55614-210)