EAGLE MEDICATED AROMATIC- 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:

Borden Company (Private) Limited

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 joint 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 ■ redness is present ■ conditions affect children under 12 years of age

Authorization status:

OTC monograph not final

Summary of Product characteristics

EAGLE MEDICATED AROMATIC- CAMPHOR MENTHOL METHYL SALICYLATE OIL
BORDEN COMPANY (PRIVATE) LIMITED
_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._
----------
EAGLE MEDICATED OIL AROMATIC
_ACTIVE INGREDIENTS_
Camphor 7%
Menthol 16%
Methyl Salicylate 35%
_PURPOSE_
External Analgesic
External Analgesic
External Analgesic
_USES_
For the temporary relief of minor aches and pains of muscles and joint
associated with
■ simple backache ■ arthritis ■ strains
■ bruises ■ sprains
_WARNINGS_
■ FOR EXTERNAL USE ONLY ■ Avoid getting into eyes and mucous
membranes
WHEN USING THIS PRODUCT
■ do not apply to wound or damaged skin ■ do not bandage tightly
■ do not use
otherwise than as directed
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
■ redness is
present ■ conditions affect children under 12 years of age
KEEP THIS DRUG OUT OF REACH OF CHILDREN
to avoid accidental poisoning. In case of accidental ingestion,
contact a doctor or Poison
Control Center immediately. IF PREGNANT OR BREAST-FEEDING, ask a
health professional
before use
_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.
_INACTIVE INGREDIENTS_
eucalyptus oil, light mineral oil, spike lavender oil
PACKAGE LABEL
EAGLE MEDICATED AROMATIC
camphor menthol methyl salicylate oil
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:43405-009
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) -
UNII:5TJD82A1ET)
CAMPHOR
(SYNTHETIC)
7 g in 100 mL
MEN