Drug Facts

Active ingredients

Colloidal Oatmeal 0.5%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Warnings

For external use only.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Directions

Apply as needed

Water, stearic acid, glycerin, c12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalene, phenoxyethanol, caprylyl glycol. xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, triethyl citrate, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, cinnamomum camphora linalooliferum wood extract, citrus limon (lemon) peel extract, punica granatum seed extract, rubus idaeus (raspberry) fruit extract, vaccinium macrocarpon (cranberry) seed oil, ceramide NP, ananas sativus (pineapple) fruit extract, citrus paradisi (grapefruit) peel extract, cucumis melo (melon) fruit extract, passiflora incarnata fruit extract, pimpinella anisum (anise) fruit extract, pyrus malus (apple) fruit extract, rosa damascene flower extract, Theobroma cacao (cocoa) extract, tsuga canadensis oil, vaccinium macrocarpon (cranberry) fruit extract, vanilla planifolia fruit extract

Questions:

888-FAB-3063

MADE IN USA

FIRST AID BEAUTY LTD

NEWTON, MA 02458

WWW.FIRSTAIDBEAUTY.COM

PRINCIPAL DISPLAY PANEL - 14.0 oz (396.8 g)

First Aid Beauty

FAB

Ultra Repair® Cream

Intense Hydration

Skin Protectant Colloidal Oatmeal

Cranberry Pomegranate Natural Infusion

Net Wt. 14.0 oz (396.8 g)

FAB

FIRST AID BEAUTY FAB ULTRA REPAIR INTENSE HYDRATION SKIN PROTECTANT CRANBERRY POMEGRANATE
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69423-565
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
TSUGA CANADENSIS LEAF OIL (UNII: Q1S51LGQ0G)
MUSKMELON (UNII: ZV095H5633)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
APPLE (UNII: B423VGH5S9)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE SODIUM (UNII: MP1J8420LU)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
PINEAPPLE (UNII: 2A88ZO081O)
CERAMIDE NP (UNII: 4370DF050B)
VANILLA BEAN (UNII: Q74T35078H)
RASPBERRY (UNII: 4N14V5R27W)
LEMON PEEL (UNII: 72O054U628)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
CRANBERRY (UNII: 0MVO31Q3QS)
GRAPEFRUIT PEEL (UNII: 3582N05Q44)
ANISE (UNII: 21C2F5E8RE)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
COCOA (UNII: D9108TZ9KG)
POMEGRANATE SEED (UNII: 7294Z34NS7)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69423-565-39	396.8 g in 1 JAR; Type 0: Not a Combination Product	01/01/2023
2	NDC:69423-565-56	56 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	01/01/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)