Zihua Embrocation
FDA Label NDC 49980-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hong Kong Zihua Pharmaceutical Ltd. for the product Zihua Embrocation (NDC 49980-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Camphor 11%

Menthol 15%

Methyl salicylate 15%

Purpose

external analgesic

external analgesic

external analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

■ For external use only

■ avoid getting into the eyes or on mucous membranes

■ discontinue use if excessive irritation of the skin develops

When Using This Product

■ do not apply to wound or damaged skin.

■ do not bandage tightly

Stop Use And Ask A Doctor If

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

■ Pain persists for more than 10 days conditions

■ redness is present

■ conditions affect children under 12 years of age

Keep Out Of Reach Of Children

to avoid accidental poisoning. If swallowed, get medical help or contact a poison control center right away.

Directions

■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily

■ Apply liberally and gently rub into affected area

■ Children under 12 years of age, consult a doctor before using

■ Do not use otherwise than as directed

Inactive Ingredients

Eucalyptus oil, FDC Blue No. 1 Al Lake, FDC Red No. 40 Al Lake, lavender oil, mineral oil

Package Label

Image Description (Zihuaembrctnlbl)

Image Description (Zihuaembrctnlbl)

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