Insta-relief Dm

Insta-relief Dm
SPL v2
SPL
SPL Set ID 6ef66fb9-9f49-409d-9503-175c7555ee9e
Route
TOPICAL
Published
Effective Date 2018-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Aloe Vera Leaf Water Benzyl Alcohol Medium-chain Triglycerides Carboxypolymethylene Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Cetyl Alcohol Lime Oil Carrot Ethylhexylglycerin Eucalyptus Oil Glycerin Lavender Oil Dimethyl Sulfone Phenoxyethanol Potassium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-05

Description

Lidocaine HCL 4.00% Menthol 1.00%


Medication Information

Description

Lidocaine HCL 4.00% Menthol 1.00%

Section 55105-1

Topical Anesthetic

Warnings
  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
Directions:
  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily
  • Children under two-years of age: consult a physician.
Do Not Apply
  • to wounds or damaged skin.
  • Do not bandage tightly.
Indications:

For the temporary relief of pain and itching assoicated with minor burns sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Package Labeling:

Active Ingredients

Lidocaine HCL 4.00%

Menthol 1.00%

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alchol, Caprylic/Capric Triglyceride, Carbomer, Cetearyl Alcohol, Cetereth-20, Cetyl Alcohol, Citrus Aurantifolia (Orange) Oil, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, 1-Arginine, Lavandula Angustifolia (Lavender) Oil, Lecithin, Methylsulfonylmethane (MSM), Phenoxyethanol, Potassium Hydroxide

Additional Information:

Store at room temperature.

If Pregnant Or Breast Feeding,

contact physician

Keep Out of Reach of Children.

If swallowed, consult physician.


Structured Label Content

Section 55105-1 (55105-1)

Topical Anesthetic

Warnings (WARNINGS)
  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
Directions: (DIRECTIONS:)
  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily
  • Children under two-years of age: consult a physician.
Do Not Apply (Do not apply)
  • to wounds or damaged skin.
  • Do not bandage tightly.
Indications: (INDICATIONS:)

For the temporary relief of pain and itching assoicated with minor burns sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Package Labeling:

Active Ingredients (ACTIVE INGREDIENTS)

Lidocaine HCL 4.00%

Menthol 1.00%

Other Ingredients: (OTHER INGREDIENTS:)

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alchol, Caprylic/Capric Triglyceride, Carbomer, Cetearyl Alcohol, Cetereth-20, Cetyl Alcohol, Citrus Aurantifolia (Orange) Oil, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, 1-Arginine, Lavandula Angustifolia (Lavender) Oil, Lecithin, Methylsulfonylmethane (MSM), Phenoxyethanol, Potassium Hydroxide

Additional Information:

Store at room temperature.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

contact physician

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, consult physician.


Advanced Ingredient Data


Raw Label Data

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