Grandall (as Pld) - Calmadol Ointment (48201-004)

Grandall (as Pld) - Calmadol Ointment (48201-004)
SPL v11
SPL
SPL Set ID 31b7f84e-8b66-4d31-8e9c-279d0af2fe64
Route
TOPICAL
Published
Effective Date 2015-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (6 g) Menthol (1.9 g) Salicylic Acid (10 g)
Inactive Ingredients
Stearic Acid Glyceryl Stearate Se Turpentine Peppermint Oil Lauryl Sulfate Trolamine Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-07-08
Description

Drug Facts

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Description

Drug Facts

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

If pregnant or breast-feeding, or if you have sensitive skin,ask a healthcare professional before use.

Purpose:

External Analgesic

Warnings

For external use only

Directions
  • Use only as directed.
  • Adults and chrldren older than 12 years of age, apply cream to the affected area not more than 3 to 4 trmes daily.
  • For children less than 12 years of age: ask a doctor
Do Not Use
  • on wounds
  • on damaged skin
  • with heating pad
  • on children under 12 years of age
Package Labeling

ARTHRITIS

CALMADOL

NET WT. 6 oz (170.1G)

Active Ingredients:

Camphor 6.00%

Menthol 1.90%

Methyl Salicylate 10.00%

Inactive Ingredients

Puified Water (Aqua), Stearic Acid, Glyceryl Stearate, Turpentine, Mentha Piperita (Pepperment) Oil, TEA-Lauryl Sulfate, Triethanolamine, Methylparaben, Propylparaben.

When Using This Product
  • Avoid contact with eyes and mucous membranes
  • Do not bandage tightly
Stop Use and Ask A Doctor If
  • Condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within few days.

Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, or if you have sensitive skin,ask a healthcare professional before use.

Purpose:

External Analgesic

Warnings

For external use only

Directions
  • Use only as directed.
  • Adults and chrldren older than 12 years of age, apply cream to the affected area not more than 3 to 4 trmes daily.
  • For children less than 12 years of age: ask a doctor
Do Not Use (Do not use)
  • on wounds
  • on damaged skin
  • with heating pad
  • on children under 12 years of age
Package Labeling

ARTHRITIS

CALMADOL

NET WT. 6 oz (170.1G)

Active Ingredients:

Camphor 6.00%

Menthol 1.90%

Methyl Salicylate 10.00%

Inactive Ingredients

Puified Water (Aqua), Stearic Acid, Glyceryl Stearate, Turpentine, Mentha Piperita (Pepperment) Oil, TEA-Lauryl Sulfate, Triethanolamine, Methylparaben, Propylparaben.

When Using This Product (When using this product)
  • Avoid contact with eyes and mucous membranes
  • Do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within few days.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:05.516136 · Updated: 2026-03-14T23:13:16.476899