Gg Tender Calm

SPL v3

SPL

SPL Set ID e673d8bd-2573-9f04-e053-2995a90a172a

Route

TOPICAL

Published

Effective Date 2014-10-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol (0.44 g) Zinc Oxide (20.625 g)

Inactive Ingredients

Glycerin Ferric Oxide Red Lanolin Light Mineral Oil .alpha.-tocopherol Acetate Thymol Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-08-17

Description

Menthol 0.44% w/w Zinc Oxide 20.625% w/w

Purpose

Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant

Medication Information

Purpose

Menthol 0.44% w/w…………….……External Analgesic

Zinc Oxide 20.625% w/w………………. Skin Protectant

Description

Menthol 0.44% w/w Zinc Oxide 20.625% w/w

Uses

A moisture barrier that prevents and helps heal skin irritations from;

urine
diarrhea
perspiration
fistula drainage
feeding tube site leakage
wound drainage (peri-wound skin)
minor burns
cuts
scrapes
itching

Warnings:

■For external use only ■Not for deep or puncture wounds ■Avoid contact with eyes

Active Ingredients

Menthol 0.44% w/w

Zinc Oxide 20.625% w/w

Inactive Ingredients

Calamine, Glycerine, Lanolin, Light Liquid Parafﬁn, Petrolatum, Thymol, Tocopheryl Acetate

Principal Display Panel

Dosage & Administration:

Clean skin with mild skin cleanser
Pat dry or allow to air dry
Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection

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

Keep Out of Reach of Children

Keep Out Of Reach Of Children

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

Structured Label Content

Uses (uses)

A moisture barrier that prevents and helps heal skin irritations from;

urine
diarrhea
perspiration
fistula drainage
feeding tube site leakage
wound drainage (peri-wound skin)
minor burns
cuts
scrapes
itching

Purpose

Menthol 0.44% w/w…………….……External Analgesic

Zinc Oxide 20.625% w/w………………. Skin Protectant

Warnings:

■For external use only ■Not for deep or puncture wounds ■Avoid contact with eyes

Active Ingredients

Menthol 0.44% w/w

Zinc Oxide 20.625% w/w

Inactive Ingredients

Calamine, Glycerine, Lanolin, Light Liquid Parafﬁn, Petrolatum, Thymol, Tocopheryl Acetate

Principal Display Panel

Dosage & Administration:

Clean skin with mild skin cleanser
Pat dry or allow to air dry
Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection

Stop Use and Ask A Doctor If (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

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep Out Of Reach Of Children

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"uses": "A moisture barrier that prevents and helps heal skin irritations from; urine diarrhea perspiration fistula drainage feeding tube site leakage wound drainage (peri-wound skin) minor burns cuts scrapes itching", "Purpose": "Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant", "Warnings:": "■For external use only ■Not for deep or puncture wounds ■Avoid contact with eyes", "Active Ingredients": "Menthol 0.44% w/w Zinc Oxide 20.625% w/w", "Inactive Ingredients": "Calamine, Glycerine, Lanolin, Light Liquid Parafﬁn, Petrolatum, Thymol, Tocopheryl Acetate", "Dosage & Administration:": "Clean skin with mild skin cleanser Pat dry or allow to air dry Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection", "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", "Keep Out Of Reach Of Children": "Keep Out Of Reach Of Children If swallowed , get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:14.434240 · Updated: 2026-03-14T23:06:44.003626