BONICA EASEX PAIN RELIEVING (camphor- synthetic, menthol, methyl salicylate patch

Bonica EaseX Pain Relieving by

Drug Labeling and Warnings

Bonica EaseX Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Planet (Anhui) Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Purpose

Topical analgesic

Use

For temporary relief of pain

Warnings

For external use only

Do not use

More than one patch on your body at a time  On cut, irritated or swollen skin  On puncture wounds  For more than one week without consulting a doctor  If you are allergic to any active or inactive ingredients  If pouch is damaged or opened

When using this product

Use only as directed  Read and follow all directions and warnings  Do not allow contact with the eyes  Do not use at the same time as other topical anesthetics  Do not bandage tightly or apply local heat (such as heating pads) to the area of use  Do not microwave  Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can product serious adverse effects is a child or pet chews or ingests this patch.

Stop use and ask a doctor if

Conditions worsen  Redness is present  Irritation develops  Symptoms persist for more than 7 days or clear up and occur again within a few days  You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a poison Control Center right away.

Directions

Adults and children 12 years of age and over:

Clean and dry affected area  Carefully remove backing from patch  Apply sticky side of patch to affected area  Use one patch for up to 8 hours  Discard patch after single use  Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Children under 12 years of age:consult a physician

Other information

Store in a clean, dry place outside of direct sunlight        Protect from excessive heat

Inactive ingredients

A-tocopherol acetate Antioxidant 1010 ESIS Fumed Silica Mineral Oil Polyisobutylene Terpene Resin

Package Labeling:

INGREDIENTS AND APPEARANCE

BONICA EASEX PAIN RELIEVING 
camphor (synthetic), menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75568-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	31 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	60 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
MINERAL OIL (UNII: T5L8T28FGP)
TERPENE RESIN (UNII: GR35AH6YDN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75568-036-01	1 in 1 BOX	07/01/2025
1		360 in 1 POUCH
1		0.33 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 Drug	M	07/01/2025

Labeler - Planet (Anhui) Pharmaceutical Co., Ltd. (618456104)

Registrant - Planet (Anhui) Pharmaceutical Co., Ltd. (618456104)

Establishment
Name	Address	ID/FEI	Business Operations
Planet (Anhui) Pharmaceutical Co., Ltd.		618456104	manufacture(75568-036)