Cryomax Cooling Gel

Cryomax Cooling Gel
SPL v1
SPL
SPL Set ID 0a0ae5ba-9fac-45f6-e063-6294a90ad555
Route
TOPICAL
Published
Effective Date 2023-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (9.5 g)
Inactive Ingredients
Horse Chestnut Alcohol Fd&c Blue No. 1 Carbomer 940 Centella Asiatica Leaf Camphor Oil Eucalyptus Oil Methyl Salicylate Glycerin Water Hedera Helix Leaf Melaleuca Cajuputi Leaf Oil Polyglyceryl-4 Caprate Ruscus Aculeatus Root Sodium Hydroxide Fd&c Yellow No. 5 Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-01

Description

Menthol 9.5%


Medication Information

Warnings and Precautions

For external use only.

When using this product avoid contact with eyes. Use only as directed. Do not bandage tightly or use with heating pad. Do not apply to wounds or damaged skin.

Flammable: keep away from fire or flame.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days, redness is present, excessive irritation of the skin develops.

Indications and Usage

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration
  • adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: consult a physician. Clean the affected area. Shake the airless bottle and squeeze a small amount of the cooling foam gel onto hand and apply it to the affected area. Repeat as necessary.
Description

Menthol 9.5%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Aesculus Hippocastanum (Horse Chestnut) Leaf Extract, Alcohol Denat., Blue 1, Carbomer, Centella Asiatica Extract, Cinnamomum (Camphor) Bark Oil, Eucalyptus Globulus Leaf Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycerin, Hedera Helix (Ivy) Leaf Extract, Melaleuca Leucadendron Cajoput Oil, Mentha Piperita (Peppermint) Oil, Polyglyceeryl-4 Caprate, Ruscus Aculeatus Root Extract, Sodium Hydroxide, Water, Yellow 5

Section 51945-4

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 9.5%


Structured Label Content

Indications and Usage (34067-9)

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration (34068-7)
  • adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: consult a physician. Clean the affected area. Shake the airless bottle and squeeze a small amount of the cooling foam gel onto hand and apply it to the affected area. Repeat as necessary.
Warnings and Precautions (34071-1)

For external use only.

When using this product avoid contact with eyes. Use only as directed. Do not bandage tightly or use with heating pad. Do not apply to wounds or damaged skin.

Flammable: keep away from fire or flame.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days, redness is present, excessive irritation of the skin develops.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Aesculus Hippocastanum (Horse Chestnut) Leaf Extract, Alcohol Denat., Blue 1, Carbomer, Centella Asiatica Extract, Cinnamomum (Camphor) Bark Oil, Eucalyptus Globulus Leaf Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycerin, Hedera Helix (Ivy) Leaf Extract, Melaleuca Leucadendron Cajoput Oil, Mentha Piperita (Peppermint) Oil, Polyglyceeryl-4 Caprate, Ruscus Aculeatus Root Extract, Sodium Hydroxide, Water, Yellow 5

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 9.5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)