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ZIHUA EMBROCATION Cooling Pain Relief

Medically reviewed on April 23, 2018

Dosage form: oil
Ingredients: CAMPHOR (SYNTHETIC) 11g in 100mL, MENTHOL 15g in 100mL, METHYL SALICYLATE 15g in 100mL
Labeler: Uncle Bill Trading USA Inc.
NDC Code: 49952-004

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

ZIHUA EMBROCATION  COOLING PAIN RELIEF
camphor menthol methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49952-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)11 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL15 g  in 100 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
LAVENDER OIL 
MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:49952-004-011 BOTTLE, GLASS in 1 BOX
1NDC:49952-004-2626 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/15/2014
Labeler - Uncle Bill Trading USA Inc. (795709307)
Establishment
NameAddressID/FEIOperations
Hong Kong Zihua Pharmaceutical Ltd.663989580manufacture(49952-004)

 
Uncle Bill Trading USA Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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