EAGLE MEDICATED- menthol methyl salicylate oil

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Saadav alates:

Eagle Indo Pharma, PT

Manustamisviis:

TOPICAL

Retsepti tüüp:

OTC DRUG

Näidustused:

Topical Analgesic Topical Analgesic temporarily relieves minor muscle and joint pain due to : ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains ■ excessive skin irritation develops ■ pain worsens or does not improve within 7 days, or clears up and appears again in a few days

Volitamisolek:

OTC monograph not final

Toote omadused

EAGLE MEDICATED- MENTHOL METHYL SALICYLATE OIL
EAGLE INDO PHARMA, PT
_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 BRAND MEDICATED OIL
_ACTIVE INGREDIENT_
Menthol 14.5%
Methyl Salicylate 30.0%
_PURPOSE_
Topical Analgesic
Topical Analgesic
_USES_
temporarily relieves minor muscle and joint pain due to : ■ simple
backache ■ arthritis
■ strains ■ bruises
■ sprains
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
■ use only as directed
■ do not get into eyes or mucous membranes
■ do not apply to wound or damaged skin.
■ do not bandage tightly
STOP USE AND ASK A DOCTOR IF
■ excessive skin irritation develops
■ pain worsens or does not improve within 7 days, or clears up and
appears again in a
few days
_KEEP THIS DRUG OUT OF REACH OF CHILDREN_
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
■ Adults and children 2 years and over: apply to affected area not
more than 3 to 4
time daily.
■ Children under 2 years of age: ask a doctor
_INACTIVE INGREDIENTS_
D&C Yellow No. 11, D&C Green No. 6, ethyl alcohol, mineral oil, rose
oil
PACKAGE LABEL
EAGLE MEDICATED
menthol methyl salicylate oil
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:60954-002
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
Eagle Indo Pharma, PT
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
14.5 g
in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ 4LPZ )
METHYL SALICYLATE
30 g in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
D&C YELLOW NO. 11 (UNII: 44F3HYL954)
ALCOHOL (UNII: 3K9958V90M)
MINERAL OIL (UNII: T5L8T28FGP)
ROSE OIL (UNII: WUB68Y35M7)
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:60954-