Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3033b1b3-21b7-9b5b-e063-6294a90a54c5
Route
VAGINAL
Published
Effective Date 2024-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.1 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-01-01

Description

ALLANTOIN


Medication Information

Warnings and Precautions

Warnings: 1. If you notice any unusual symptoms or side effects such as redness, swelling, or itching in the area where the cosmetic product was applied, particularly after direct sunlight exposure during or after use, seek advice from a specialist or health care professional 2. Do not apply on broken or irritated skin. 3. Precautions for Safe Handling: a. Keep out of reach of children b. Store in a cool, dry place and away from direct sunlight. 4. Use exclusively on the external genital area; avoid internal vaginal application 5. Follow the recommended usage instructions on the product packaging 6. Avoid application on children under 3 years old 7. Avoid use during pregnancy and refrain from application around the external genital area immediately before childbirthPrecautions for Safe Handling: a. Keep out of reach of children

Indications and Usage

Dispense an adequate amount onto the palm of your hand, then gently massage and spread the rich creamy

lather before rinsing thoroughly with water.

Dosage and Administration

for vaginal use only

Description

ALLANTOIN

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

Disodium Cocoamphodiacetate

Sodium Chloride

1,2-Hexanediol

Decyl Glucoside

Butylene Glycol

Hexylene Glycol

Lactobacillus/Soybean Ferment Extract

Streptococcus Thermophilus Ferment

Bifida Ferment Lysate

Lactobacillus Ferment Lysate

Hydrogenated Lecithin

Ceramide NP

Allantoin

Trehalose

Betaine

Sodium PCA

Citric Acid

Disodium EDTA

Methylpropanediol

Caprylyl Glycol

Ethylhexylglycerin

Steareth-30

Section 51945-4

Section 55105-1

The product, made from naturally derived safe surfactants, effectively maintains cleanliness and moisture

in the external genital area, providing a refreshing cleansing sensation without causing irritation.

Section 55106-9

ALLANTOIN


Structured Label Content

Indications and Usage (34067-9)

Dispense an adequate amount onto the palm of your hand, then gently massage and spread the rich creamy

lather before rinsing thoroughly with water.

Dosage and Administration (34068-7)

for vaginal use only

Warnings and Precautions (34071-1)

Warnings: 1. If you notice any unusual symptoms or side effects such as redness, swelling, or itching in the area where the cosmetic product was applied, particularly after direct sunlight exposure during or after use, seek advice from a specialist or health care professional 2. Do not apply on broken or irritated skin. 3. Precautions for Safe Handling: a. Keep out of reach of children b. Store in a cool, dry place and away from direct sunlight. 4. Use exclusively on the external genital area; avoid internal vaginal application 5. Follow the recommended usage instructions on the product packaging 6. Avoid application on children under 3 years old 7. Avoid use during pregnancy and refrain from application around the external genital area immediately before childbirthPrecautions for Safe Handling: a. Keep out of reach of children

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

Disodium Cocoamphodiacetate

Sodium Chloride

1,2-Hexanediol

Decyl Glucoside

Butylene Glycol

Hexylene Glycol

Lactobacillus/Soybean Ferment Extract

Streptococcus Thermophilus Ferment

Bifida Ferment Lysate

Lactobacillus Ferment Lysate

Hydrogenated Lecithin

Ceramide NP

Allantoin

Trehalose

Betaine

Sodium PCA

Citric Acid

Disodium EDTA

Methylpropanediol

Caprylyl Glycol

Ethylhexylglycerin

Steareth-30

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

The product, made from naturally derived safe surfactants, effectively maintains cleanliness and moisture

in the external genital area, providing a refreshing cleansing sensation without causing irritation.

Section 55106-9 (55106-9)

ALLANTOIN


Advanced Ingredient Data


Raw Label Data

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