PAIN RELIEVING COOLING- menthol, unspecified form gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)

Available from:

J.R. Watkins, LLC.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

EXTERNAL ANALGESIC For the temporary relief of minor aches and pains of muscles and joints associated with - simple backache - arthritis - strains - sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAIN RELIEVING COOLING- MENTHOL, UNSPECIFIED FORM GEL
J.R. WATKINS, LLC.
----------
PAIN RELIEVING COOLING GEL
DRUG FACTS
ACTIVE INGREDIENT
MENTHOL 3%
PURPOSE
EXTERNAL ANALGESIC
USES
For the temporary relief of minor aches and pains of muscles and
joints associated with
simple backache
arthritis
strains
sprains
WARNINGS
FOR EXTERNAL USE ONLY.
FLAMMABLE:Keep away from fire or flame.
DO NOT USE
on wounds or damaged skin
with a heading pad
WHEN USING THIS PRODUCT
avoid contact with eyes, nostrils and mouth
do not bandage tightly
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
rash or irritation occurs
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center right away.
DIRECTIONS
Use only as directed
Adults and children 2 years and older: Apply liberally to painful area
not more than 3-
4 times daily.
Children under 2 years of age: Ask a doctor.
Wash hands carefully after using
OTHER INFORMATION
do not use if tamper evident seal is not intact
store away from children
store in dry, well-ventilated conditions at room temperature
(59-77°F)
INACTIVE INGREDIENTS
Acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 60, SD
alcohol 40B,
tromethamine, water
QUESTIONS OR COMMENTS?
1-888-384-1945
PRINCIPAL DISPLAY PANEL - 93 G TUBE LABEL
TRUSTED REMEDIES
SINCE 1868
ESTD
1868
J.R.
WATKINS
REMEDIES FOR BODY
PAIN RELIEVING
COOLING
GEL
WITH
NATURAL
MENTHOL
TEMPORARY
RELIEF FOR
MUSCLES & JOINTS
NET WT. 3.3 OZ (93 g)
®
PAIN RELIEVING COOLING
menthol, unspecified form gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:72342-020
ROUTE OF ADMINISTRATION
TOPICAL
J.R. Watkins, LLC.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED
FORM - UNII:L7T10EIP3A)
MENTHOL, UNSPECIFIED
FORM
3 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
T