SPL v2
SPL
SPL Set ID 3617ca21-7543-6d2e-e063-6394a90aea89
Route
ORAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camellia Oil (0.3 g)
Inactive Ingredients
Pseudolarix Amabilis Bark Sophora Flavescens Root Rheum Palmatum Root Sanguisorba Officinalis Root Smilax Glabra Tuber Zinc Oxide Ferric Oxide Red Phellodendrine Stemona Japonica Whole

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-01-01

Description

Camellia Oil 0.3%


Medication Information

Description

Camellia Oil 0.3%

Uses

First aid to help prevent bacterial contamination or skin infection, and fortemporary relief of pain and itching associated with minor burns, scaldssunburns, cuts, and scrapes.

Lable

Section 43683-2

no

Warning

For external use only. When using this product do not get into eyes. Stopuse and ask a doctor if your condition worsens, does not improve, persistsin more than 7 days, or occurs again after a few days. Consult a doctorbefore using on animal bites or serious burns. Keep out ofreach of childrenf swallowed, call poison control or seek medical help.

Directions

For adults and children 2 years ofage or older. Clean the affected area.Apply a small amount of the ointment to the affected area, not more than3 to 4 times daily. For children under 2 years ofage, ask a doctor before use.

Active Ingredient

Camellia Oil 0.3%

Other Information

Store in a cool, dry place.

This is not a toy and should be kept out of reach of young children.

Discard the product if the packaging has been opened. Do not use.

Inactive Ingredient

Pseudolarix Amabilis Bark, Sophora Flavescens Root Extract, RheumPalmatum Root, Sanguisorba Officinalis , Smilax Glabra Rhizome, Calamina,Phellodendri Chinensis Cortex, Stemona Japonica Whole.

Dosage & Administration

Apply not more than 3 to 4 times

When Using This Product

Do not wear this product directly on skin.

Be aware of low-temperature burns.

Stop Use and Ask A Doctor If

pain worsens or persists, or if youexperience any of these symptoms: burning, itching, rash, or other changes in theskin where the product was placed.

Keep Out of Reach of Children.

if swallowed, call poison control or seek medical help.


Structured Label Content

Uses (USES)

First aid to help prevent bacterial contamination or skin infection, and fortemporary relief of pain and itching associated with minor burns, scaldssunburns, cuts, and scrapes.

Lable

Section 43683-2 (43683-2)

no

Warning

For external use only. When using this product do not get into eyes. Stopuse and ask a doctor if your condition worsens, does not improve, persistsin more than 7 days, or occurs again after a few days. Consult a doctorbefore using on animal bites or serious burns. Keep out ofreach of childrenf swallowed, call poison control or seek medical help.

Directions

For adults and children 2 years ofage or older. Clean the affected area.Apply a small amount of the ointment to the affected area, not more than3 to 4 times daily. For children under 2 years ofage, ask a doctor before use.

Active Ingredient (Active ingredient)

Camellia Oil 0.3%

Other Information (Other information)

Store in a cool, dry place.

This is not a toy and should be kept out of reach of young children.

Discard the product if the packaging has been opened. Do not use.

Inactive Ingredient (Inactive ingredient)

Pseudolarix Amabilis Bark, Sophora Flavescens Root Extract, RheumPalmatum Root, Sanguisorba Officinalis , Smilax Glabra Rhizome, Calamina,Phellodendri Chinensis Cortex, Stemona Japonica Whole.

Dosage & Administration (Dosage & administration)

Apply not more than 3 to 4 times

When Using This Product (When using this product)

Do not wear this product directly on skin.

Be aware of low-temperature burns.

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

pain worsens or persists, or if youexperience any of these symptoms: burning, itching, rash, or other changes in theskin where the product was placed.

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

if swallowed, call poison control or seek medical help.


Advanced Ingredient Data


Raw Label Data

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