ZIHUA EMBROCATION COOLING PAIN RELIEF- camphor menthol methyl salicylate oil

ZIHUA EMBROCATION by

Drug Labeling and Warnings

ZIHUA EMBROCATION by is a Otc medication manufactured, distributed, or labeled by Hong Kong Zihua Pharmaceutical Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ZIHUA EMBROCATION  COOLING PAIN RELIEF
camphor menthol methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49980-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	11 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49980-003-01	1 in 1 BOX
1	NDC: 49980-003-26	26 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/15/2014

Labeler - Hong Kong Zihua Pharmaceutical Ltd. (663989580)

Establishment
Name	Address	ID/FEI	Business Operations
Hong Kong Zihua Pharmaceutical Ltd.		663989580	manufacture(49980-003)