nursing cream

SPL v7

SPL

SPL Set ID 4832b2c4-fc6b-26d6-e054-00144ff8d46c

Route

topical

Published

Effective Date 2016-04-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

althaea officinalis root (1 [hp_X]) calendula officinalis flower chamomile

Inactive Ingredients

yellow wax olive oil

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2016-04-01

Purpose

Skin Protectant

Description

Skin Protectant

Medication Information

Warnings

Warnings

For external use only.

■ Do not use on ■ on deep wounds ■ animal bites ■ serious burns

■ Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days

■ When using this product keep out of eyes. Rinse with water to remove.

Purpose

Skin Protectant

Inactive Ingredients

Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax).

Description

Skin Protectant

Principal Display Panel

Otc Purpose

Skin Protectant

Indications & Usage

■ temporarily protects skin related to ■ nursing ■ pregnancy

■ helps prevent and temporarily protects and helps relieve ■ chapped or cracked nipples

■ temporarily protects and helps relieve minor skin irritation

Storage and Handlin

Store at room temperature.

Otc Active Ingredients

Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)

Organic Chamomilla Recutita (Matricaria) Flower Oil 1X (HPUS)

Organic Althaea Officinalis (Marshmallow) Root 1X (HPUS)

Dosage & Administration

Clean and dry nipple area before application. Apply as often as needed. Clean and dry nipple area before nursing.

Keep Out of Reach of Children

Keep Out of Reach of Children

Structured Label Content

Warnings

Warnings

For external use only.

■ Do not use on ■ on deep wounds ■ animal bites ■ serious burns

■ Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days

■ When using this product keep out of eyes. Rinse with water to remove.

Inactive Ingredients

Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax).

Principal Display Panel

Otc Purpose (OTC Purpose)

Skin Protectant

Indications & Usage

■ temporarily protects skin related to ■ nursing ■ pregnancy

■ helps prevent and temporarily protects and helps relieve ■ chapped or cracked nipples

■ temporarily protects and helps relieve minor skin irritation

Storage and Handlin

Store at room temperature.

Otc Active Ingredients (OTC Active Ingredients)

Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)

Organic Chamomilla Recutita (Matricaria) Flower Oil 1X (HPUS)

Organic Althaea Officinalis (Marshmallow) Root 1X (HPUS)

Dosage & Administration

Clean and dry nipple area before application. Apply as often as needed. Clean and dry nipple area before nursing.

Keep Out of Reach of Children

Keep Out of Reach of Children

Advanced Ingredient Data

[{"name": "ALTHAEA OFFICINALIS ROOT", "unii": "TRW2FUF47H", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "51.7", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLIVE OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "51.7", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "51.7", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Warnings": "Warnings For external use only. ■ Do not use on ■ on deep wounds ■ animal bites ■ serious burns ■ Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days ■ When using this product keep out of eyes. Rinse with water to remove.", "OTC Purpose": "Skin Protectant", "Indications & Usage": "■ temporarily protects skin related to ■ nursing ■ pregnancy ■ helps prevent and temporarily protects and helps relieve ■ chapped or cracked nipples ■ temporarily protects and helps relieve minor skin irritation", "Storage and Handlin": "Store at room temperature.", "Inactive Ingredients": "Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax).", "OTC Active Ingredients": "Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS) Organic Chamomilla Recutita (Matricaria) Flower Oil 1X (HPUS) Organic Althaea Officinalis (Marshmallow) Root 1X (HPUS)", "Dosage & Administration": "Clean and dry nipple area before application. Apply as often as needed. Clean and dry nipple area before nursing.", "Keep Out of Reach of Children": "Keep Out of Reach of Children"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:09.612999 · Updated: 2026-03-14T23:17:34.098873