drug facts

drug facts
SPL v6
SPL
SPL Set ID 19e4b812-67c6-49fd-833a-b432100363f5
Route
topical
Published
Effective Date 2018-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (natural) (90 mg) menthol, unspecified form (13 mg)
Inactive Ingredients
petrolatum titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-12-01

Purpose

Camphor - Topical Analgesic Menthol - Topical Analgesic

Description

Camphor 9% Menthol 1.3%


Medication Information

Warnings

For external use only

Uses

temporarily relieves minor aches and pains of muscles and joints

Purpose

Camphor - Topical Analgesic

Menthol - Topical Analgesic

Directions
  • adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor
Inactive Ingredients

fragrance, petrolatum, titanium dioxide

Description

Camphor 9% Menthol 1.3%

Questions?

1-877-636-2677 MON-FRI 9AM to 5PM (EST)

Active Ingredients

Camphor 9%

Menthol 1.3%

When Using This Product
  • do not get into eyes
  • do not apply to wounds or to damaged skin
  • do not bandage tightly
  • do not heat, microwave, or add to hot water as this may cause splattering and result in burns
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

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

Package/label Principal Display Panel

Structured Label Content

Warnings

For external use only

Uses

temporarily relieves minor aches and pains of muscles and joints

Purpose

Camphor - Topical Analgesic

Menthol - Topical Analgesic

Directions
  • adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor
Inactive Ingredients (Inactive ingredients)

fragrance, petrolatum, titanium dioxide

Questions?

1-877-636-2677 MON-FRI 9AM to 5PM (EST)

Active Ingredients (Active ingredients)

Camphor 9%

Menthol 1.3%

When Using This Product (When using this product)
  • do not get into eyes
  • do not apply to wounds or to damaged skin
  • do not bandage tightly
  • do not heat, microwave, or add to hot water as this may cause splattering and result in burns
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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