SPL v2
SPL
SPL Set ID 284c29a3-5722-ce70-e063-6394a90a7fa0
Route
TOPICAL
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (0.03 g) Menthol (0.05 g)
Inactive Ingredients
Castor Oil Lavender Oil 1-palmitoyl-2-oleoyl-sn-glycero-3-(phospho-rac-(1-glycerol)) Willow Bark Arnica Montana Flower Disodium .alpha.-tocopheryl Phosphate, D- Cetyl Myristoleate Glyceryl Laurate Glyceryl Ricinoleate Demeton-s-methylsulfone Aloe Vera Leaf Glycerin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Shea Butter Turmeric Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-09

Description

Topical Analgesic

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Topical Analgesic

Section 51945-4

Section 55106-9

Menthol 5%

Camphor 3%

Warning

For external use only

Stop Use

Stop use and consult a doctor if conditions worsens.

When Using

Use only as directed.

Indications

For temporary relief of minor aches andf Pains of muscles joints.

Pregnancy Or Breast Feeding

Ask a health professional before use.


Structured Label Content

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Menthol 5%

Camphor 3%

Purpose

Topical Analgesic

Warning

For external use only

Stop Use

Stop use and consult a doctor if conditions worsens.

When Using

Use only as directed.

Indications

For temporary relief of minor aches andf Pains of muscles joints.

Pregnancy Or Breast Feeding (Pregnancy or Breast feeding)

Ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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