Label: CETAPHIL SOOTHING GEL CREAM- allantoin cream
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- NDC Code(s): 0299-4105-00, 0299-4105-05, 0299-4105-10, 0299-4105-15
- Packager: Galderma Laboratories, L.P.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 28, 2022
If you are a consumer or patient please visit this version.
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- Active ingredients......Purpose
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- Uses
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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.
- Directions
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Inactive Ingredients
ALOE BARBADENSIS LEAF JUICE POWDER, BUTYROSPERMUM PARKII (SHEA) OIL, CAPRYLYL GLYCOL, CAPRYLYL/CAPRYL GLUCOSIDE, CITRIC ACID, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYLPROPANEDIOL, PANTHENOL, PANTOLACTONE, PHENOXYETHANOL, POLYISOBUTENE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, TOCOPHEROL, WATER
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PRINCIPLE DISPLAY PANEL - 8 OZ TUBE
#1 Doctor Recommended
Sensitive Skincare BrandCetaphil®
Soothing
Gel Cream
with Aloe
Irritated, Sensitive Skin
Fast absorbing formula
helps rescue, prevent and
relieve dry, stressed skinSkin Protectant Allantoin
Five Skin Sensitivity SignNET WT 8 OZ (226 g)
Distributed By:
Galderma Laboratories, L.P.
Fort Worth, TX 76177 USAAll trademarks are the property of their respective owners.
Made in Canada.
cetaphil.com
P55452-1
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INGREDIENTS AND APPEARANCE
CETAPHIL SOOTHING GEL CREAM
allantoin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-4105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin 5 mg in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Sheanut Oil (UNII: O88E196QRF) Caprylyl Glycol (UNII: 00YIU5438U) Caprylyl/Capryl Oligoglucoside (UNII: E00JL9G9K0) Citric Acid Monohydrate (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Soybean Oil (UNII: 241ATL177A) Sunflower Oil (UNII: 3W1JG795YI) Methylpropanediol (UNII: N8F53B3R4R) Panthenol (UNII: WV9CM0O67Z) Pantolactone, (R)- (UNII: J288D7O0JS) Phenoxyethanol (UNII: HIE492ZZ3T) Polyisobutylene (1000 Mw) (UNII: 5XB3A63Y52) Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) (UNII: 1DXE3F3OZX) Tocopherol (UNII: R0ZB2556P8) Water (UNII: 059QF0KO0R) Sorbitan Monooleate (UNII: 06XEA2VD56) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0299-4105-00 10 g in 1 TUBE; Type 0: Not a Combination Product 02/17/2020 2 NDC:0299-4105-05 85 g in 1 TUBE; Type 0: Not a Combination Product 02/17/2020 3 NDC:0299-4105-10 226 g in 1 TUBE; Type 0: Not a Combination Product 02/17/2020 4 NDC:0299-4105-15 453 g in 1 JAR; Type 0: Not a Combination Product 02/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/17/2020 Labeler - Galderma Laboratories, L.P. (047350186) Establishment Name Address ID/FEI Business Operations G Production Inc. 251676961 manufacture(0299-4105)