QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM ULTRA STRENGTH- camphor, menthol, methyl salicylate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941), MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

QUALITY CHOICE (Chain Drug Marketing Association)

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Camphor - Topical analgesic Menthol - Topical analgesic Methyl salicylate - Topical analgesic temporarily relieves minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - sprains - bruises

Authorization status:

OTC monograph not final

Summary of Product characteristics

QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM ULTRA
STRENGTH- CAMPHOR, MENTHOL, METHYL SALICYLATE CREAM
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
_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._
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QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM
ACTIVE INGREDIENT
Camphor 4%
Menthol 10%
Methyl salicylate 30%
PURPOSE
Camphor - Topical analgesic
Menthol - Topical analgesic
Methyl salicylate - Topical analgesic
USES
temporarily relieves minor aches and pains of muscles and joints
associated with:
simple backache
arthritis
strains
sprains
bruises
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
on wounds or damaged skin
with a healing pad
on a child under 12 years of age with arthritis-like conditions
ASK A DOCTOR BEFORE USE IF YOU HAVE
redness over the affected area
WHEN USING THIS PRODUCT
use only as directed
avoid contact with eyes or mucous membranes
do not bandage tightly
STOP USE AND ASK A DOCTOR IF
skin redness or excessive irritation of the skin occurs
condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few
days
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away (1-800-222-
1222)
DIRECTIONS
adults and children 12 years and over; apply to affected area not more
than 3 to 4
times daily
children under 12 years of age; consult a physician
OTHER INFORMATION
Store at 20-25 C (68-77F)
do not use if tube seal under cap is broken
INACTIVE INGREDIENTS
carbomer homopolymer type c, cetostearyl alcohol, cetyl alcohol,
glyceryl monostearate,
methylparaben, peg-100 stearate, polysorbate 60, propylparaben,
stearic acid,
trolamine, water
PRINCIPAL DISPLAY PANEL
QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM ULTRA
STRENGTH
camphor, menthol, methyl salicylate cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63868-692
ROUTE OF A