SPL v2
SPL
SPL Set ID 30c3df30-e0c6-4efa-e063-6294a90ac40a
Route
TOPICAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Reynoutria Multiflora Root (0.02 mg) Rosmarinus Officinalis (rosemary) Leaf Oil (40 mg) Zingiber Officinale (ginger) Root Oil (0.5 mg)
Inactive Ingredients
Butylene Glycol Tocopherol Hydrogenated Castor Oil Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-20

Description

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL ZINGIBER OFFICINALE (GINGER) ROOT OIL REYNOUTRIA MULTIFLORA ROOT


Medication Information

Warnings and Precautions

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product.Discontinue use if sians of irritation or rash occur. Store in a cool and dry.

Description

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL ZINGIBER OFFICINALE (GINGER) ROOT OIL REYNOUTRIA MULTIFLORA ROOT

Section 44425-7

Store in a cool and dry.

Section 50565-1

Please keep out of reach of children. Do not swallow.

Section 50566-9

Discontinue use if sians of irritation or rash occur.

Section 50567-7

Apply appropriate amount of this product to hair and gently massage with fingertips.

Section 50570-1

Discontinue use if sians of irritation or rash occur.

Section 51727-6

GLYCERIN

BUTYLENE GLYCOL

HYDROGENATED CASTOR OIL

TOCOPHEROL

Section 51945-4

Section 55105-1

1. Contains coconut oll, which helps hydrate and moisturize the scalp and hairmoisturizes and helps you maintain thehealth of your hair and scalp.

2. Helps reduce dandruff,increase hair thickness, and make hair lock smooth and tiay.

3. Conlains herbal extracls to help restore the lost nulrients of the scalp and rejuvenate the hair.

Section 55106-9

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL

ZINGIBER OFFICINALE (GINGER) ROOT OIL

REYNOUTRIA MULTIFLORA ROOT


Structured Label Content

Warnings and Precautions (34071-1)

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product.Discontinue use if sians of irritation or rash occur. Store in a cool and dry.

Section 44425-7 (44425-7)

Store in a cool and dry.

Section 50565-1 (50565-1)

Please keep out of reach of children. Do not swallow.

Section 50566-9 (50566-9)

Discontinue use if sians of irritation or rash occur.

Section 50567-7 (50567-7)

Apply appropriate amount of this product to hair and gently massage with fingertips.

Section 50570-1 (50570-1)

Discontinue use if sians of irritation or rash occur.

Section 51727-6 (51727-6)

GLYCERIN

BUTYLENE GLYCOL

HYDROGENATED CASTOR OIL

TOCOPHEROL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

1. Contains coconut oll, which helps hydrate and moisturize the scalp and hairmoisturizes and helps you maintain thehealth of your hair and scalp.

2. Helps reduce dandruff,increase hair thickness, and make hair lock smooth and tiay.

3. Conlains herbal extracls to help restore the lost nulrients of the scalp and rejuvenate the hair.

Section 55106-9 (55106-9)

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL

ZINGIBER OFFICINALE (GINGER) ROOT OIL

REYNOUTRIA MULTIFLORA ROOT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)