ASTONEA COLD THERAPY- menthol 4% gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

ASTONEA LABS PRIVATE LIMITED

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains sprains

Summary of Product characteristics

ASTONEA COLD THERAPY- MENTHOL 4% GEL
ASTONEA LABS PRIVATE LIMITED
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ASTONEA COLD THERAPY 4% MENTHOL
Menthol 4%
Topical Analgesic
Temporary relief from minor aches and pains of sore muscles and joints
associated with:
arthritis
backache
strains
sprains
FOR EXTERNAL USE ONLY
FLAMMABLE:Keep away from excessive heat or open flame
ASK A DOCTOR BEFORE USE IF YOU HAVE: sensitive skin
Stop use and ask a doctor if
condition worsens or symptoms persist for more than 7 days or clear up
and occur
again within a few days.
When using this product
■avoid contact with eyes or mucous membranes ■do not apply to
wounds or damaged
skin ■ do not use with other ointments, creams, sprays or liniments
■ do not apply to
irritated skin or if excessive irritation develops ■do not bandage
■ wash hands alter use
with cool water ■do not use with heating pad or device
IF PREGNANT OR BREASTFEEDING, ask a health professional before use
Keep out of reach of children: If accidentally ingested, get medical
help or contact a
poison Control immediately (1800-222-1222)
DIRECTIONS
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER:Rub a thin film over
affected areas
not more than daily: massage not necessary
CHILDREN UNDER 2 YEARS OF AGE :Consult physician
camphor, carbopol 940, DMDM hydantoin, edetate disodium, FD&C yellow
no. 5, FD&C
blue no. 1, isopropyl alcohol, PEG 40
hydrogenated castor oil, propylene glycol, sodium hydroxide, water
ASTONEA LABS PRIVATE LIMITED
ASTONEA COLD THERAPY
menthol 4% gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:77338-007
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
4 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)
GLYCERIN (UNII: PDC6A3C0OX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE SODIUM (UNII: MP1J8420LU)
CARBOMER 940 (UNII: 4Q93RCW27E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C YELLOW NO. 5 (UNII: