Welly Calm Balm
FDA Label NDC 72663-069

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Welly Health Pbc for the product Welly Calm Balm (NDC 72663-069). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep this and all drugs out of the reach of children., directions, inactive ingredients, principal display panel .57 oz tube, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Keep This And All Drugs Out Of The Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Principal Display Panel .57 Oz Tube

→ Principal Display Panel -can

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc Acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

For temporary relief from pain and itching associated with :

insect bites
minor burns
sunburn
minor skin irritations
rashes due to poison ivy, poison oak, and poison sumac

Dries the oozing and weeping of poison

ivy
oak
sumac

Warnings

For external use only

Do not use

on large areas of the body
with any other product containing diphenhydramine , even one taken by the mouth.

Ask a Doctor before use

on chicken pox
on measles

When using this product avoid contact with eyes.

Stop use and ask a doctor if

conditions worsen or does not improve within 7 days
symptoms persist for more than 7 days or clear up and occur agian within a few days

Keep This And All Drugs Out Of The Reach Of Children.

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

do not use more than directed
adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily
children under 2 years of age , consult a doctor

Other Information

Store at controlled room temperature 20°-25°C (68° - 77°F)
Close the cap tightly after use

Inactive Ingredients

Cetyl Alcohol, Citric Acid, Diazolldinyl Urea, Glyceryl Sterate, Methylparaben, Polyethylene Glycol Monosterate 1000, Propylene Glycol, Propylparaben, Sodium Citrate , Purified Water