42c93789-9758-54b7-e063-6394a90ac398

Set ID
42c93789-9758-54b7-e063-6394a90ac398
Manufacturer
Bullet point LLC | ShanghaiChuangshiMedicalTechnology(Group)Co.,Ltd.
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:41:56

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Menthol 4.0% w/w ...... Purpose: Topical Analgesic

OTC - PURPOSE SECTION

Purpose (Menthol) Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Use Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains When using this product • Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with a heating pad or device • Store in a cool, dry place Stop use if • Condition worsens or if symptoms persist for more than 7 days, or clear up and recur.

Warnings

WARNINGS SECTION

Warnings For external use only

WARNINGS AND PRECAUTIONS SECTION

Flammable • Keep away from fire or flame

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding Ask a health professional before use

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children 12 years of age and over: Rub a thin film over affected areas not more than 4 times daily Massage not necessary Children under 12 years old: Consult physician

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive Ingredients Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

OTC - QUESTIONS SECTION

Questions or Comments Call +1-888-806-6834

Products

NDC Codes

Ingredients

NameUNIIKind
FD&C YELLOW NO. 5I753WB2F1MIACT
TROLAMINE9O3K93S3TKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
FRANKINCENSER9XLF1R1WMIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
GLYCERINPDC6A3C0OXIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
ALCOHOL 95%7528N5H79BIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

Complete SPL Sections

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Menthol 4.0% w/w ...... Purpose: Topical Analgesic

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose (Menthol) Topical Analgesic

WARNINGS SECTION

WARNINGS SECTION

Warnings For external use only

WARNINGS AND PRECAUTIONS SECTION

WARNINGS AND PRECAUTIONS SECTION

Flammable • Keep away from fire or flame

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Use Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains When using this product • Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with a heating pad or device • Store in a cool, dry place Stop use if • Condition worsens or if symptoms persist for more than 7 days, or clear up and recur.

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor if Condition worsens or if symptoms persist for more than 7 days. or clear up and reoccur.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding Ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If swallowed, get medical help or contact the Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children 12 years of age and over: Rub a thin film over affected areas not more than 4 times daily Massage not necessary Children under 12 years old: Consult physician

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Other Information Avoid storing the product in direct sunlight Protect the product from excessive moisture.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive Ingredients Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or Comments Call +1-888-806-6834

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML SHA-256
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XML bytes
25302

Legacy File Index

FolderFileDate
otc42c9380a-3630-9175-e063-6294a90a5db9.xml2025-11-05
otcPrincipal Display Panel-Menthol Gel.jpg2025-11-05