Cetaphil Cracked Skin Repair

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
Generic name: DIMETHICONE
Manufacturer: Galderma Laboratories, L.P.
Product type: HUMAN OTC DRUG
SPL set ID: 27d74e0f-8359-4c59-bf7f-acade7f4545c
SPL ID: 54f6994b-a5ad-4dd6-82ec-c2578b46c89e
Version: 4
Effective date: 2023-11-30
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:37:15

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	openfda.brand_name
generic name		DIMETHICONE	openfda.generic_name
manufacturer name		Galderma Laboratories, L.P.	openfda.manufacturer_name
ndc	package	0299-4114-00	openfda.package_ndc
ndc	product	0299-4114	openfda.product_ndc
ndc11	package	00299411400	derived:openfda.package_ndc
rxcui		198605	openfda.rxcui
spl id		54f6994b-a5ad-4dd6-82ec-c2578b46c89e	id
spl set id		27d74e0f-8359-4c59-bf7f-acade7f4545c	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.