Cirlutone Ointment
FDA Label NDC 71917-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Herbal Health Llc for the product Cirlutone (NDC 71917-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Storage And Handling

→ Inactive Ingredient

→ Otc - Questions

→ Description

→ Package Label.principal Display Panel

Otc - Active Ingredient

Camphor 0.6%

Otc - Purpose

Camphor 0.6%...............Topical Analgesic

Indications & Usage

For the temporary relief of pain associated with:

sunburn
minor cuts
scrapes

Warnings

For External Use only.

Flammable: keep away from fire or flame

Otc - When Using

When using this product

avoid contact with eyes or mucous membrane
use only as directed

Otc - Stop Use

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 2 yrs of age: consult a doctor.

Storage And Handling

Store in a cool & dry place
Do not use if tamper evident seal is broken or missing

Inactive Ingredient

Angelica anemala, Emulsifying Wax NF, Fragrance, Frankincense Oil, Isopropyl alcohol, Ligusticum wallichii, Magnolia liliflora, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sophora, Syzgium armaticum