80465-100-08

80465-100-08
SPL v1
SPL
SPL Set ID 05b84fd2-8d8f-9249-e063-6294a90ae29f
Route
TOPICAL
Published
Effective Date 2023-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (0.9 g)
Inactive Ingredients
.alpha.-hexylcinnamaldehyde Linalool, (+/-)- Hydroxycitronellal Farnesol .alpha.-amylcinnamaldehyde Benzyl Salicylate .beta.-citronellol, (r)- Water Alcohol Glycerin Polysorbate 20 Arnica Montana Flower Limonene, (+/-)- Fd&c Blue No. 1 Citronella Oil Fd&c Yellow No. 5 Benzyl Benzoate Geraniol Citral Eugenol

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-03

Description

Camphor 1%


Medication Information

Warnings and Precautions

For external use only. · Ask a doctor before use if you have redness over affected area.

Description

Camphor 1%

Use

For the temporary relief of pain.

Section 50565-1

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

Section 50566-9

Condition worsens.

Redness is present.

Irritation develops.

Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

Section 50567-7

Avoid contact with eyes.

Use only as directed.

Do not apply to wounds or damaged, broken, or irritated skin.

Do not bandage tightly or use with a heating pad

If you experience an allergic reaction, discontinue use, and consult a physician.

Section 51727-6

Alcohol Denat, Water (Aqua), Glycerin, Polysorbate 20, Fragrance, Parfum, Arnica Montana Flower Extract, Cymbopogon Nardus (Citronella) Oil, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090), Benzyl Benzoate, Limonene, Benzyl Salicylate, Geraniol, Hexyl Cinnamal, Citral, Amyl Cinnamal, Citronellol, Linalool, Hydroxycitronellal, Eugenol, Farnesol.

Section 53414-9

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1

External Analgesic

Section 55106-9

Camphor 1%

Section 60561-8

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Directions

Adults and Children over 12 years

Apply to affected area not more than three to four times daily.

Children under 12 years of age: do not use, consult a doctor.

Natureance Body Balm


Structured Label Content

Use (USE)

For the temporary relief of pain.

Warnings and Precautions (34071-1)

For external use only. · Ask a doctor before use if you have redness over affected area.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Condition worsens.

Redness is present.

Irritation develops.

Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

Section 50567-7 (50567-7)

Avoid contact with eyes.

Use only as directed.

Do not apply to wounds or damaged, broken, or irritated skin.

Do not bandage tightly or use with a heating pad

If you experience an allergic reaction, discontinue use, and consult a physician.

Section 51727-6 (51727-6)

Alcohol Denat, Water (Aqua), Glycerin, Polysorbate 20, Fragrance, Parfum, Arnica Montana Flower Extract, Cymbopogon Nardus (Citronella) Oil, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090), Benzyl Benzoate, Limonene, Benzyl Salicylate, Geraniol, Hexyl Cinnamal, Citral, Amyl Cinnamal, Citronellol, Linalool, Hydroxycitronellal, Eugenol, Farnesol.

Section 53414-9 (53414-9)

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1 (55105-1)

External Analgesic

Section 55106-9 (55106-9)

Camphor 1%

Section 60561-8 (60561-8)

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Directions (DIRECTIONS)

Adults and Children over 12 years

Apply to affected area not more than three to four times daily.

Children under 12 years of age: do not use, consult a doctor.

Natureance Body Balm (NATUREANCE BODY BALM)


Advanced Ingredient Data


Raw Label Data

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