FDA label 5f555e14-8dcc-4838-e053-2991aa0aa2f7

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
4d8dbefc-e117-4fba-9261-2446a28c8954
SPL ID
5f555e14-8dcc-4838-e053-2991aa0aa2f7
Version
2
Effective date
2017-12-02
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:32:14

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 1. Must ONLY be used externally as it might cause rare case of allergic reaction(s) if used improperly. 2. Avoid use in the following cases: a. People who are known to experience allergic reaction from any one of the active ingredient(s) b. People with anemia c. People with circulatory problems/disorders d. Around the eye area and/or mucous membrane e. Presence of infection, inflammation, flares and/or sensitivity 3. MUST use with caution when: a. Using along with other acne products or when the possibility of experiencing skin dryness, irritation is increased due to the use of this product immediately followed by prior use of other acne products b. Have experienced allergic reaction (i.e., rash, flare, itch, and/or blisters) from medication or cosmetic products in the past c. Around toddlers and/or children d. Suffering from renal insufficiency or failure 4. Caution during application: a. ALWAYS perform a patch test three days prior to use. b. Do NOT use on area(s) with flares, minor dermatitis, and open or festering wound as it can aggravate the symptoms felt. c. Avoid extensive use since side effects might be felt. d. Avoid contact on eye and lip areas as well as around mucous membrane. If in contact, wash off with ample amount of water and follow doctor's instructions on severe cases. e. Avoid exposure in environments at temperatures above 122°F (50°C) immediately after application. 5. Caution for usage on children: a. Thin skin tissues, allowing for easy penetration of products on children, can cause side effects when it is improperly used. Therefore, use on toddlers is PROHIBITED. b. Extensive use for extended period of time on children should also be AVOIDED. 6. Caution when storing and handling: a. When stored in temperatures above 122°F (50°C), presence of chloroaniline is favorable and can bring on the methemoglobinemia. Store in room temperature setting to avoid extreme conditions of heat. In addition, please refrain from contact with fabric that has been washed, pressed, sterilized in heat. b. Keep away from direct sunlight when storing. c. Keep out of reach of children; when contents are swallowed, seek IMMEDIATE medical attention.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.