DYNAFREEZE- menthol liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Performance Health LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

DYNAFREEZE- MENTHOL LIQUID
PERFORMANCE HEALTH LLC
_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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DYNAFREEZE
_DRUG FACTS_
_ACTIVE INGREDIENT_
Menthol 3.5%
_PURPOSE_
Cooling Pain Relief
_USES:_
Temporary relief from minor aches and pains of sore muscles and joints
associated with
arthritis
backache
strains
sprains
_WARNINGS:_
For external use only
ASK A DOCTOR BEFORE USE IF YOU HAVE:
sensitive skin, are pregnant or breast feeding
WHEN USING THIS PRODUCT:
Avoid contact with eyes or mucous membranes
Do not apply to wounds, damaged or irritated skin, or if excessive
irritation develops
Do not bandage or use with heating pad or device, ointments, creams,
sprays or
liniments
After applying, wash hands with cool water
STOP USE AND ASK A DOCTOR IF:
Condition worsens, symptoms persist more than 7 days, or clear up and
then recur
KEEP OUT OF REACH OF CHILDREN:
If ingested, get medical help. Contact Poison Control Center
immediately
_DIRECTIONS:_
ADULTS / CHILDREN 2 YEARS AND OLDER: Massage onto affected area up to
4 times
daily
CHILDREN UNDER 2 YEARS OF AGE: Consult physician
_OTHER INFORMATION:_
Store in a cool dry place, lid closed tightly. Keep away from
excessive heat or open
flame.
_INACTIVE INGREDIENTS:_
water, isopropyl alcohol, yerba mate extract, menthol, carbomer,
triethanolamine, silicon
dioxide, methylparaben, glycerine, propylene glycol, FD and C blue 1
_QUESTIONS OR COMMENTS?_
1-800-246-3733
PACKAGE LABELING:
DYNAFREEZE
menthol liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:59316-301
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
35 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
Performance Health LLC
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ILEX PARAGUARIEN