1135 - dynarub ndc 67777-113-50

1135 - dynarub ndc 67777-113-50
SPL v3
SPL
SPL Set ID 7f853941-a2d7-ed26-e053-2991aa0aa9ee
Route
topical
Published
Effective Date 2016-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (10 g) salicylic acid (15 g)
Inactive Ingredients
glycerin glyceryl monostearate isopropyl myristate methylparaben phenoxyethanol sodium hydroxide stearic acid edetate disodium anhydrous water allantoin carboxypolymethylene dimethicone cetyl alcohol titanium dioxide alpha-tocopherol acetate xanthan gum potassium cetyl phosphate propylparaben polysorbate 20

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-09-12
Purpose

Topical Analgesic

Description

Menthol 10%

Medication Information

Warnings

For external use only

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains

Purpose

Topical Analgesic

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: Consult a doctor
Other Information

store at 20°-25°C (68°-77°F).

Inactive Ingredients



Allantoin, Carbomer (Ultrez 10), Cetyl Alcohol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methyl Paraben, Phenoxyethanol, Potassium Cetyl Phosphate, Propyl Paraben, Purified Water, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Tween 20, Vitamin E, Xanthan Gum

Description

Menthol 10%

Label

Section 50565-1

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

Do Not Use On

wounds or damaged skin

Active Ingredient

Menthol 10%

When Using This Product
  • avoid contact with eyes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Structured Label Content

Warnings

For external use only

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains

Purpose

Topical Analgesic

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: Consult a doctor
Other Information

store at 20°-25°C (68°-77°F).

Inactive Ingredients



Allantoin, Carbomer (Ultrez 10), Cetyl Alcohol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methyl Paraben, Phenoxyethanol, Potassium Cetyl Phosphate, Propyl Paraben, Purified Water, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Tween 20, Vitamin E, Xanthan Gum

Label

Section 50565-1 (50565-1)

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

Do Not Use On (Do not use on)

wounds or damaged skin

Active Ingredient

Menthol 10%

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:29.275954 · Updated: 2026-03-14T23:05:15.511736