ZIMS MAX FREEZE- 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:

KOBAYASHI Healthcare International, Inc.

INN (International Name):

MENTHOL, UNSPECIFIED FORM

Composition:

MENTHOL, UNSPECIFIED FORM 37 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: - Simple backache - Arthritis - Strains - Bruises - Sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

ZIMS MAX FREEZE- MENTHOL, UNSPECIFIED FORM GEL
KOBAYASHI HEALTHCARE INTERNATIONAL, INC.
_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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ZIM'S™ MAX FREEZE
_DRUG FACTS_
SHAKE WELL
ACTIVE INGREDIENT
Natural Menthol USP 3.7%
PURPOSE
Topical Analgesic
USES
For the temporary relief of minor aches and pains of muscles and
joints associated with:
Simple backache
Arthritis
Strains
Bruises
Sprains
WARNINGS
FOR EXTERNAL USE ONLY
FLAMMABLE
Keep away from fire or flame and heated surfaces
DO NOT USE
if you are allergic to any ingredient in Zim's Max-Freeze
on open wounds, damaged or irritated skin
with a heating pad or TENS device
after expiration date
WHEN USING THIS PRODUCT
do not bandage tightly
do not use otherwise than as directed
avoid contact with eyes or mucous membranes
STOP USE AND ASK A DOCTOR IF
condition worsens
rash, itching, redness or excessive irritation of the skin develops
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
IF PREGNANT OR BREAST FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center right away.
DIRECTIONS
ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER:
apply to affected area not more than 4 times daily
massage painful area until absorbed into skin
wash hands after each use with cold water
CHILDREN UNDER 12 YEARS OF AGE: consult a doctor
OTHER INFORMATION
store in a cool place away from direct sunlight
store with lid closed tightly
INACTIVE INGREDIENTS
Aloe Barbadensis Leaf Extract,
Arnica Extract, Camphor, Carbomer,
Ethylhexylglycerin,
Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Phenoxyethanol,
Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine,
Water.
1
Consumer Comments Call: 800-319-2225
Distributed by:
KOBAYASHI CONSUMER PRODUCTS, LLC
P.O. Box 1191, Dalton, GA 3072