Cetaphil Cracked Skin Repair Balm

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)

Brand name: Cetaphil Cracked Skin Repair Balm
Generic name: DIMETHICONE
Manufacturer: Galderma Laboratories, L.P.
Product type: HUMAN OTC DRUG
SPL set ID: 5efb3ef0-6ee9-4ef8-b81e-90bd1825c956
SPL ID: 40277fde-372e-4ded-b7f8-15168d11582a
Version: 3
Effective date: 2023-11-30
Source export date: 2026-11-06
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/9d5577a314a25811fefbde4767c9b37f3913d9a65fdc458c6336b5aed532339e/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 08:49:11

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		Cetaphil Cracked Skin Repair Balm	openfda.brand_name
generic name		DIMETHICONE	openfda.generic_name
manufacturer name		Galderma Laboratories, L.P.	openfda.manufacturer_name
ndc	package	0299-4115-00	openfda.package_ndc
ndc	product	0299-4115	openfda.product_ndc
ndc11	package	00299411500	derived:openfda.package_ndc
rxcui		200010	openfda.rxcui
spl id		40277fde-372e-4ded-b7f8-15168d11582a	id
spl set id		5efb3ef0-6ee9-4ef8-b81e-90bd1825c956	set_id
unii		92RU3N3Y1O	openfda.unii

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 For external use only. When using this product ● Do not get into eyes. 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. Do not use on ● deep or puncture wounds ● animal bites ● serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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