OTC Medication Information: ZIMS MAX FREEZE LEG CRAMP

ZIMS MAX FREEZE LEG CRAMP- camphor (synthetic), menthol, unspecified form and methyl salicylate liquid
KOBAYASHI Healthcare International, Inc.

Drug Facts

Active ingredients Purpose
Camphor 3.1% Topical analgesic
Menthol 5% Topical analgesic
Methyl Salicylate 11.5% Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
  • Cramps

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 this product
  • on open wounds, damaged or irritated skin
  • after expiration date

When using this product

  • to avoid excess application, press applicator gently against skin
  • do not bandage tightly or cover with wrap or use heating pad or TENS device
  • do not use 1 hour prior to bathing or within 30 minutes after bathing
  • do not use other 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, burning sensation, swelling or blistering of the skin develops
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If you are pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children and pets. If swallowed, get medical help, or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and over:

  • apply to affected area not more than 4 times daily

Children under 12 years of age:

  • consult a doctor

Other information

  • allergy alert: If prone to allergic reaction from aspirin or salicylates, consult doctor before use
  • store in a cool place away from direct sunlight
  • store with cap closed tightly

Inactive ingredients

Dimethyl Isosorbide, Propylene Glycol, SD Alcohol 40-B, Tea Tree Oil, Tocopheryl Acetate, Water, Zingiber Officinale (Ginger) Root Extract.

Distributed by:
KOBAYASHI Consumer Products, LLC
P.O. Box 1191, Dalton, GA 30722

PRINCIPAL DISPLAY PANEL — 89 mL Bottle Carton

ZIM’S™
MAX-
FREEZE

For Minor Pain Caused by
LEG CRAMPS

Relax & Relieve
Muscles

Fast Acting
Liquid

Easy to Use
Angled Bottle

Pain Relieving
Liquid
3 fl oz (89mL)

3 POWERFUL INGREDIENTS

PRINCIPAL DISPLAY PANEL -- 89 mL Bottle Carton
(click image for full-size original)
ZIMS MAX FREEZE LEG CRAMP
menthol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54273-011
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 31 mg in 1 mL
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 50 mg in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 115 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHYL ISOSORBIDE
PROPYLENE GLYCOL
ALCOHOL
TEA TREE OIL
.ALPHA.-TOCOPHEROL ACETATE
WATER
GINGER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54273-011-01 1 BOTTLE, WITH APPLICATOR in 1 CARTON contains a BOTTLE, WITH APPLICATOR
1 89 mL in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (54273-011-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph drug M017 09/01/2022
Labeler — KOBAYASHI Healthcare International, Inc. (156391729)
Registrant — KOBAYASHI America Manufacturing, LLC (079852150)
Establishment
Name Address ID/FEI Operations
KOBAYASHI America Manufacturing, LLC 079852150 PACK (54273-011), LABEL (54273-011)

Revised: 11/2023 KOBAYASHI Healthcare International, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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