Eagle Balm Pharma

Eagle Balm Pharma
SPL v3
SPL
SPL Set ID 87614869-9675-2c76-e053-2a95a90a48a9
Route
TOPICAL
Published
Effective Date 2021-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (11 g) Menthol (15 g)
Inactive Ingredients
Paraffin Petrolatum Peppermint

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-15

Description

Menthol 15% Camphor 11%

Purpose

External Analgesic External Analgesic


Medication Information

Purpose

External Analgesic

External Analgesic

Description

Menthol 15% Camphor 11%

Uses

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

Warnings

For External Use Only

Directions

■ Adults and children 12 years of age: apply to affected area not more than 3 - 4 times daily. ■children under 12 years of age, consult a doctor before using

Package Label

Other Information

■ Store in a a cool, dry place

Active Ingredients

Menthol 15%

Camphor 11%

Inactive Ingredients

fragrance, paraffin, peppermint oil, petrolatum

When Using This Product

■ Avoid getting itno the eyes or on mucous membranes ■do not apply to wounds or damaged skin ■do not bandage tightly or use with a heating pad ■do not use otherwise than as directed

Stop Use and Ask A Doctor If

■Conditions worsens ■symptoms persist for more than 7 days or clear up and occur again within a few days ■redness is present

Keep Out of Reach of Children

In case of accidental ingestion contact a doctor or Poison Control Center immediately.


Structured Label Content

Uses

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

Purpose

External Analgesic

External Analgesic

Warnings

For External Use Only

Directions

■ Adults and children 12 years of age: apply to affected area not more than 3 - 4 times daily. ■children under 12 years of age, consult a doctor before using

Package Label

Other Information

■ Store in a a cool, dry place

Active Ingredients

Menthol 15%

Camphor 11%

Inactive Ingredients

fragrance, paraffin, peppermint oil, petrolatum

When Using This Product (When using this product)

■ Avoid getting itno the eyes or on mucous membranes ■do not apply to wounds or damaged skin ■do not bandage tightly or use with a heating pad ■do not use otherwise than as directed

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■Conditions worsens ■symptoms persist for more than 7 days or clear up and occur again within a few days ■redness is present

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

In case of accidental ingestion contact a doctor or Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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