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

Purpose

External Analgesic

Description

Drug Facts

Medication Information

Warnings

For external use only

Uses

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

simple backache
arthritis
strains
bruises
sprains

Purpose

External Analgesic

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

Inactive Ingredients

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

Description

Drug Facts

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

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%

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

Warnings

For external use only

Uses

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

simple backache
arthritis
strains
bruises
sprains

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

Inactive Ingredients

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

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

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%

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

[{"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE SE", "unii": "FCZ5MH785I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TURPENTINE", "unii": "XJ6RUH0O4G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURYL SULFATE", "unii": "DIQ16UC154", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (NATURAL)", "unii": "N20HL7Q941", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "1.9", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For prompt temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of childern. If swallowed, get medical help or contact a Poison Control Center immediately.", "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."}

Additional Information

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