ZIHUA EMBROCATION COOLING PAIN RELIEF- camphor menthol methyl salicylate oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Uncle Bill Trading USA Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

external analgesic external analgesic external analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains ■ 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

ZIHUA EMBROCATION COOLING PAIN RELIEF- CAMPHOR MENTHOL METHYL
SALICYLATE OIL
UNCLE BILL TRADING USA INC.
_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 T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 9 52-0 0 4
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -
UNII:5T