Eagle Brand Eagle Balm

Eagle Brand Eagle Balm
SPL v3
SPL
SPL Set ID 0ba74dba-ec98-09d7-e063-6394a90a22db
Route
TOPICAL
Published
Effective Date 2023-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4 g) Menthol (15.5 g)
Inactive Ingredients
D&c Yellow No. 11 Paraffin Petrolatum D&c Green No. 6 Eucalyptus Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-04

Description

Camphor 4% Menthol 15.5%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Camphor 4% Menthol 15.5%

Uses

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

Warnings

For external use only

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: do not use, consult a doctor.

Questions?

If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.

Package Label

20g NDC: 60954-201-20

Other Information

Store below 86°F (30°C ).

Active Ingredients
  • Camphor 4%
  • Menthol 15.5%
Inactive Ingredients

D&C Green No.6, D&C Yellow No.11, fragrance, paraffin, petrolatum

When Using This Product
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use if excessive irritation of the skin develops.
  • Do not use otherwise than as directed.
Stop Use and Ask Doctor If

Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

If Pregnant Or Breast Feeding

Ask a health professional before use.

Keep Out of Reach of Children

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


Structured Label Content

Uses

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

Purpose

External Analgesic

Warnings

For external use only

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: do not use, consult a doctor.

Questions?

If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.

Package Label

20g NDC: 60954-201-20

Other Information (Other information)

Store below 86°F (30°C ).

Active Ingredients
  • Camphor 4%
  • Menthol 15.5%
Inactive Ingredients (Inactive ingredients)

D&C Green No.6, D&C Yellow No.11, fragrance, paraffin, petrolatum

When Using This Product (When using this product)
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use if excessive irritation of the skin develops.
  • Do not use otherwise than as directed.
Stop Use and Ask Doctor If (Stop use and ask doctor if)

Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use.

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.


Advanced Ingredient Data


Raw Label Data

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