Savvy Cream
FDA Label NDC 83650-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Savvy Care And Cosmetics for the product Savvy (NDC 83650-102). 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 ingredient, purpose, uses, warnings, do not use, ask a doctor before use, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

■  temporarily relieves pain and itching associated with ■ insect bites ■ minor burns ■ sunburn ■ minor skin irritations  ■ minor cuts ■ scrapes ■ rashes due to poison ivy, poison oak, and poison sumac ■ dries the oozing and weeping of poison ivy, poison oak, and poison 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 mouth

Ask a doctor before use■ on chicken pox ■ on measles

Ask A Doctor Before Use

avoid contact with eyes

Stop Use And Ask A Doctor If

■ condition worsens, or does not improve within 7 days ■ symptoms persist for more than 7 days or clear up and occur again wihin a few days

Keep Out Of Reach Of Children

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

Directions

■ do not use more than directed 

■ adults and children2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor

Other Information

■ store at 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, propylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Package Label

Image Description (Itchcrm)

Image Description (Itchcrm)

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